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A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia

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ClinicalTrials.gov Identifier: NCT01678924
Recruitment Status : Terminated
First Posted : September 5, 2012
Results First Posted : January 7, 2020
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Neuralgia, Postherpetic
Interventions Drug: AGN-214868
Drug: AGN-214868 Placebo (Vehicle)
Enrollment 280
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AGN 214868 130µg AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Period Title: Overall Study
Started 64 63 30 123
Completed 54 51 28 105
Not Completed 10 12 2 18
Reason Not Completed
Adverse Event             1             1             0             1
Lack of Efficacy             7             2             0             5
Lost to Follow-up             0             4             0             2
Personal Reasons             2             2             2             7
Withdrawal by Subject             0             3             0             2
Unable to attend scheduled visits             0             0             0             1
Arm/Group Title AGN 214868 130µg AGN 214868 65µg AGN 214868 32.5µg Placebo Total
Hide Arm/Group Description Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 Total of all reporting groups
Overall Number of Baseline Participants 64 63 30 123 280
Hide Baseline Analysis Population Description
The safety population, consisting of patients who received 1 dose of study drug in the study, included 280 patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 63 participants 30 participants 123 participants 280 participants
66.6  (10.47) 65.3  (12.82) 65.0  (11.99) 67.0  (8.13) 66.3  (10.28)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 64 participants 63 participants 30 participants 123 participants 280 participants
18 years to less than 40 years 1 3 1 0 5
40 years to less than 65 years 20 19 12 46 97
65 years and over 43 41 17 77 178
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 63 participants 30 participants 123 participants 280 participants
Male
37
  57.8%
34
  54.0%
13
  43.3%
50
  40.7%
134
  47.9%
Female
27
  42.2%
29
  46.0%
17
  56.7%
73
  59.3%
146
  52.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 64 participants 63 participants 30 participants 123 participants 280 participants
Caucasian 56 52 26 112 246
Black 3 4 1 7 15
Asian 0 2 2 1 5
Hispanic 5 4 1 2 12
Other 0 1 0 1 2
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 64 participants 63 participants 30 participants 123 participants 280 participants
84.9  (19.15) 82.3  (17.67) 80.0  (14.48) 78.8  (17.83) 81.1  (17.86)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 64 participants 63 participants 30 participants 123 participants 280 participants
169.8  (10.22) 167.7  (10.98) 169.1  (8.91) 166.4  (9.07) 167.7  (9.83)
1.Primary Outcome
Title Change From Baseline in Average Pain Intensity Score - Cohort 1
Hide Description The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. Patients used the 11-point Likert scale, with anchors at 0 = "no pain" and 10 = "pain as bad as you can imagine" Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Two cohorts of patients with postherpetic neuralgia (PHN) were randomized to receive 1 treatment of either AGN-214868 (cohort 1: 32.5 or 65 μg; cohort 2: 130 μg) or placebo. Cohort 1 includes 154 patients from the modified intent to treat (mITT) population
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 63 30 61
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 1
-0.88
(-1.249 to -0.538)
-1.02
(-1.380 to -0.587)
-1.11
(-1.425 to -0.808)
Week 2
-1.33
(-1.746 to -0.968)
-1.56
(-1.963 to -1.017)
-1.57
(-1.970 to -1.174)
Week 3
-1.66
(-2.143 to -1.203)
-1.93
(-2.426 to -1.227)
-1.84
(-2.248 to -1.388)
Week 4
-1.78
(-2.277 to -1.310)
-2.20
(-2.721 to -1.432)
-1.98
(-2.423 to -1.482)
Week 5
-1.83
(-2.321 to -1.384)
-2.19
(-2.675 to -1.379)
-2.10
(-2.557 to -1.554)
Week 6
-1.97
(-2.442 to -1.495)
-2.07
(-2.597 to -1.297)
-2.34
(-2.755 to -1.697)
Week 7
-2.00
(-2.481 to -1.506)
-2.08
(-2.572 to -1.328)
-2.32
(-2.746 to -1.673)
Week 8
-2.11
(-2.591 to -1.618)
-2.02
(-2.530 to -1.263)
-2.40
(-2.825 to -1.745)
Week 9
-2.21
(-2.66 to -1.701)
-2.15
(-2.682 to -1.352)
-2.52
(-2.805 to -1.733)
Week 10
-2.28
(-2.679 to -1.674)
-2.29
(-2.812 to -1.481)
-2.48
(-2.743 to -1.634)
Week 11
-2.27
(-2.684 to -1.672)
-2.46
(-2.996 to -1.570)
-2.56
(-2.807 to -1.724)
Week 12
-2.20
(-2.626 to -1.600)
-2.53
(-3.061 to -1.605)
-2.65
(-2.886 to -1.783)
2.Primary Outcome
Title Change From Baseline in Average Pain Intensity Score - Cohort 2
Hide Description The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. patients used the 11-point Likert scale, with anchors at 0 = "no pain" and 10 = "pain as bad as you can imagine" Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Two cohorts of patients with postherpetic neuralgia (PHN) were randomized to receive 1 treatment of either AGN-214868 (cohort 1: 32.5 or 65 μg; cohort 2: 130 μg) or placebo. Cohort 2 includes 125 patients from the mITT population
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 64 61
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 1
-0.78
(-1.093 to -0.451)
-0.88
(-1.190 to -0.492)
Week 2
-1.12
(-1.508 to -0.701)
-1.37
(-1.791 to -0.799)
Week 3
-1.45
(-1.788 to -0.952)
-1.65
(-2.064 to -1.057)
Week 4
-1.62
(-1.934 to -1.072)
-1.90
(-2.344 to -1.269)
Week 5
-1.88
(-2.202 to -1.301)
-1.88
(-2.366 to -1.257)
Week 6
-2.04
(-2.226 to -1.305)
-1.90
(-2.339 to -1.235)
Week 7
-2.14
(-2.345 to -1.352)
-1.90
(-2.352 to -1.225)
Week 8
-2.29
(-2.405 to -1.404)
-1.96
(-2.412 to -1.270)
Week 9
-2.35
(-2.493 to -1.497)
-2.00
(-2.457 to -1.293)
Week 10
-2.44
(-2.584 to -1.557)
-2.04
(-2.515 to -1.311)
Week 11
-2.49
(-2.647 to -1.581)
-2.03
(-2.489 to -1.314)
Week 12
-2.49
(-2.659 to -1.632)
-2.03
(-2.538 to -1.354)
3.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 61 30 61
Measure Type: Number
Unit of Measure: percentage of patients
18.0 33.3 21.3
4.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 63 30 60
Measure Type: Number
Unit of Measure: percentage of patients
27.0 40.0 36.7
5.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 60 30 60
Measure Type: Number
Unit of Measure: percentage of patients
35.0 50.0 50.0
6.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease), and in 10% increments, up to 100% improvement, in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 61 30 59
Measure Type: Number
Unit of Measure: percentage of patients
37.7 53.3 50.8
7.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 59 30 57
Measure Type: Number
Unit of Measure: percentage of patients
40.7 53.3 52.6
8.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 58 30 55
Measure Type: Number
Unit of Measure: percentage of patients
41.4 50.0 54.5
9.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 7
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 60 30 57
Measure Type: Number
Unit of Measure: percentage of patients
43.3 56.7 50.9
10.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 58 30 56
Measure Type: Number
Unit of Measure: percentage of patients
43.1 50.0 55.4
11.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 55 27 52
Measure Type: Number
Unit of Measure: percentage of patients
43.6 51.9 51.9
12.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 56 28 52
Measure Type: Number
Unit of Measure: percentage of patients
46.4 53.6 55.8
13.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 11
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 53 28 52
Measure Type: Number
Unit of Measure: percentage of patients
47.2 53.6 59.6
14.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 50 27 49
Measure Type: Number
Unit of Measure: percentage of patients
48.0 63.0 63.3
15.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 63 59
Measure Type: Number
Unit of Measure: percentage of patients
14.3 20.3
16.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 62 58
Measure Type: Number
Unit of Measure: percentage of patients
25.8 27.6
17.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: percentage of patients
30.5 39.7
18.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 60 58
Measure Type: Number
Unit of Measure: percentage of patients
35.0 43.1
19.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 57 57
Measure Type: Number
Unit of Measure: percentage of patients
42.1 45.6
20.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 53 57
Measure Type: Number
Unit of Measure: percentage of patients
45.3 45.6
21.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 7
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 50 56
Measure Type: Number
Unit of Measure: percentage of patients
50.0 48.2
22.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 51 55
Measure Type: Number
Unit of Measure: percentage of patients
54.9 49.1
23.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 51 55
Measure Type: Number
Unit of Measure: percentage of patients
58.8 45.5
24.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 51 55
Measure Type: Number
Unit of Measure: percentage of patients
64.7 47.3
25.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 11
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 50 54
Measure Type: Number
Unit of Measure: percentage of patients
64.0 42.6
26.Secondary Outcome
Title Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12
Hide Description Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 44 50
Measure Type: Number
Unit of Measure: percentage of patients
61.4 40.0
27.Secondary Outcome
Title Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2
Hide Description The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient and that the patient was asked to circle their MASP on with a black marker. Areas of pain were quantified at a central reading center.
Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 61 27 60
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Square Centimeters (cm^2)
-25.07
(-37.544 to -13.564)
-34.07
(-60.871 to -4.114)
-26.10
(-38.580 to -14.053)
28.Secondary Outcome
Title Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4
Hide Description The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 62 29 60
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Square Centimeters (cm^2)
-27.65
(-40.978 to -15.412)
-25.96
(-49.316 to 0.309)
-32.23
(-48.543 to -16.214)
29.Secondary Outcome
Title Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8
Hide Description The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 56 28 55
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Square Centimeters (cm^2)
-29.86
(-45.876 to -15.566)
-37.18
(-64.825 to -1.989)
-34.04
(-48.026 to -22.134)
30.Secondary Outcome
Title Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12
Hide Description The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 57 29 54
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Square Centimeters (cm^2)
-30.99
(-46.118 to -17.138)
-31.40
(-61.185 to 3.853)
-35.03
(-53.242 to -18.425)
31.Secondary Outcome
Title Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2
Hide Description The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.
Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 57 57
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Square Centimeters (cm^2)
-9.86
(-38.087 to 18.020)
-27.52
(-43.841 to -10.854)
32.Secondary Outcome
Title Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4
Hide Description The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 58 59
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Square Centimeters (cm^2)
-22.23
(-48.893 to 3.903)
-25.67
(-42.901 to -7.909)
33.Secondary Outcome
Title Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8
Hide Description The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 53 57
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Square Centimeters (cm^2)
-42.92
(-65.580 to -23.080)
-31.95
(-47.299 to -13.978)
34.Secondary Outcome
Title Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12
Hide Description The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 54 57
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Square Centimeters (cm^2)
-36.73
(-67.719 to -8.696)
-32.60
(-49.823 to -12.574)
35.Secondary Outcome
Title Change From Baseline in Area of Allodynia - Cohort 1 - Week 2
Hide Description The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.
Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 61 27 60
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Square Centimeters (cm^2)
-40.06
(-89.750 to -12.158)
-14.42
(-34.431 to 23.824)
-52.73
(-67.258 to -24.248)
36.Secondary Outcome
Title Change From Baseline in Area of Allodynia - Cohort 1 - Week 4
Hide Description The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 62 29 60
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Square Centimeters (cm^2)
-54.12
(-118.867 to -19.566)
-23.07
(-41.985 to 19.468)
-58.14
(-70.452 to -26.048)
37.Secondary Outcome
Title Change From Baseline in Area of Allodynia - Cohort 1 - Week 8
Hide Description The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 56 28 55
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Square Centimeters (cm^2)
-74.46
(-136.541 to -43.526)
-50.47
(-75.433 to -4.124)
-71.54
(-85.155 to -37.104)
38.Secondary Outcome
Title Change From Baseline in Area of Allodynia - Cohort 1 - Week 12
Hide Description The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 57 29 54
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Square Centimeters (cm^2)
-67.71
(-130.695 to -35.611)
-39.96
(-62.646 to 8.446)
-70.46
(-92.167 to -29.970)
39.Secondary Outcome
Title Change From Baseline in Area of Allodynia - Cohort 2 - Week 2
Hide Description The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.
Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 57 57
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Square Centimeters (cm^2)
-36.66
(-59.461 to -0.328)
-60.71
(-98.564 to -36.369)
40.Secondary Outcome
Title Change From Baseline in Area of Allodynia - Cohort 2 - Week 4
Hide Description The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 58 59
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Square Centimeters (cm^2)
-54.33
(-72.041 to -13.677)
-69.39
(-116.234 to -45.112)
41.Secondary Outcome
Title Change From Baseline in Area of Allodynia - Cohort 2 - Week 8
Hide Description The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 53 57
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Square Centimeters (cm^2)
-78.78
(-99.958 to -43.748)
-75.58
(-113.401 to -50.634)
42.Secondary Outcome
Title Change From Baseline in Area of Allodynia - Cohort 2 - Week 12
Hide Description The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 54 57
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Square Centimeters (cm^2)
-77.98
(-99.148 to -36.515)
-79.99
(-129.775 to -49.428)
43.Secondary Outcome
Title Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2
Hide Description Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 48 21 50
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-17.4
(-25.67 to -10.68)
-21.2
(-30.01 to -10.09)
-15.3
(-22.76 to -7.32)
44.Secondary Outcome
Title Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4
Hide Description Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 50 25 51
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-21.9
(-29.67 to -15.57)
-20.5
(-28.34 to -11.34)
-12.3
(-19.02 to -5.01)
45.Secondary Outcome
Title Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8
Hide Description Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 51 22 49
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-22.7
(-31.18 to -15.80)
-24.8
(-34.73 to -14.45)
-19.4
(-27.27 to -10.15)
46.Secondary Outcome
Title Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12
Hide Description Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.
Arm/Group Title AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 51 23 46
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-19.2
(-27.51 to -12.14)
-21.6
(-33.46 to -9.41)
-21.5
(-28.99 to -12.79)
47.Secondary Outcome
Title Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 2
Hide Description Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 53 55
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-19.0
(-26.102 to -11.030)
-16.2
(-23.400 to -9.691)
48.Secondary Outcome
Title Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 4
Hide Description Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 52 55
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-20.6
(-27.941 to -10.867)
-20.5
(-29.487 to -13.640)
49.Secondary Outcome
Title Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 8
Hide Description Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 48 52
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-28.7
(-35.924 to -21.285)
-19.7
(-27.721 to -11.895)
50.Secondary Outcome
Title Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 12
Hide Description Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
Arm/Group Title AGN 214868 130µg Placebo
Hide Arm/Group Description:
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
Overall Number of Participants Analyzed 47 51
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-26.9
(-37.750 to -16.548)
-19.1
(-26.996 to -10.612)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AGN 214868 130µg AGN 214868 65µg AGN 214868 32.5µg Placebo
Hide Arm/Group Description Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
All-Cause Mortality
AGN 214868 130µg AGN 214868 65µg AGN 214868 32.5µg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
AGN 214868 130µg AGN 214868 65µg AGN 214868 32.5µg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/64 (3.13%)   8/63 (12.70%)   2/30 (6.67%)   10/123 (8.13%) 
Blood and lymphatic system disorders         
Anaemia  1  0/64 (0.00%)  0/63 (0.00%)  0/30 (0.00%)  1/123 (0.81%) 
Cardiac disorders         
Atrial fibrillation  2  1/64 (1.56%)  0/63 (0.00%)  0/30 (0.00%)  0/123 (0.00%) 
Myocardial infarction  2  1/64 (1.56%)  0/63 (0.00%)  0/30 (0.00%)  0/123 (0.00%) 
Angina unstable  2  0/64 (0.00%)  1/63 (1.59%)  0/30 (0.00%)  0/123 (0.00%) 
Gastrointestinal disorders         
Gastrooesophageal reflux disease  2  0/64 (0.00%)  0/63 (0.00%)  0/30 (0.00%)  1/123 (0.81%) 
General disorders         
Oedema peripheral  2  0/64 (0.00%)  0/63 (0.00%)  0/30 (0.00%)  1/123 (0.81%) 
Hepatobiliary disorders         
Cholecystitis  2  0/64 (0.00%)  2/63 (3.17%)  0/30 (0.00%)  0/123 (0.00%) 
Infections and infestations         
Pyelonephritis  2  0/64 (0.00%)  1/63 (1.59%)  0/30 (0.00%)  0/123 (0.00%) 
Erysipelas  2  0/64 (0.00%)  0/63 (0.00%)  0/30 (0.00%)  1/123 (0.81%) 
Furuncle  2  0/64 (0.00%)  0/63 (0.00%)  0/30 (0.00%)  1/123 (0.81%) 
Labyrinthitis  2  0/64 (0.00%)  0/63 (0.00%)  0/30 (0.00%)  1/123 (0.81%) 
Injury, poisoning and procedural complications         
Fractured sacrum  2  0/64 (0.00%)  0/63 (0.00%)  0/30 (0.00%)  1/123 (0.81%) 
Pubis fracture  2  0/64 (0.00%)  0/63 (0.00%)  0/30 (0.00%)  1/123 (0.81%) 
Rib fracture  2  0/64 (0.00%)  0/63 (0.00%)  0/30 (0.00%)  1/123 (0.81%) 
Urethral injury  2  0/64 (0.00%)  0/63 (0.00%)  0/30 (0.00%)  1/123 (0.81%) 
Musculoskeletal and connective tissue disorders         
Joint crepitation  2  0/64 (0.00%)  0/63 (0.00%)  0/30 (0.00%)  1/123 (0.81%) 
Osteoarthritis  2  0/64 (0.00%)  0/63 (0.00%)  0/30 (0.00%)  1/123 (0.81%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma  2  0/64 (0.00%)  1/63 (1.59%)  1/30 (3.33%)  0/123 (0.00%) 
Breast cancer  2  0/64 (0.00%)  1/63 (1.59%)  0/30 (0.00%)  1/123 (0.81%) 
Squamous cell carcinoma  2  0/64 (0.00%)  1/63 (1.59%)  0/30 (0.00%)  0/123 (0.00%) 
Adenocarcinoma of colon  2  0/64 (0.00%)  0/63 (0.00%)  1/30 (3.33%)  0/123 (0.00%) 
Malignant melanoma  2  0/64 (0.00%)  0/63 (0.00%)  1/30 (3.33%)  0/123 (0.00%) 
Nervous system disorders         
Thalamic infarction  2  0/64 (0.00%)  1/63 (1.59%)  0/30 (0.00%)  0/123 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Haemothorax  2  0/64 (0.00%)  0/63 (0.00%)  0/30 (0.00%)  1/123 (0.81%) 
Pneumothorax  2  0/64 (0.00%)  0/63 (0.00%)  0/30 (0.00%)  1/123 (0.81%) 
Respiratory failure  2  0/64 (0.00%)  0/63 (0.00%)  0/30 (0.00%)  1/123 (0.81%) 
Vascular disorders         
Aortic aneurysm  2  0/64 (0.00%)  1/63 (1.59%)  0/30 (0.00%)  1/123 (0.81%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
2
Term from vocabulary, MedDRA (18.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
AGN 214868 130µg AGN 214868 65µg AGN 214868 32.5µg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/64 (23.44%)   15/63 (23.81%)   8/30 (26.67%)   30/123 (24.39%) 
General disorders         
Injection site pain  1  6/64 (9.38%)  1/63 (1.59%)  0/30 (0.00%)  6/123 (4.88%) 
Infections and infestations         
Upper respiratory tract infection  1  4/64 (6.25%)  5/63 (7.94%)  1/30 (3.33%)  8/123 (6.50%) 
Nasopharyngitis  1  3/64 (4.69%)  5/63 (7.94%)  2/30 (6.67%)  9/123 (7.32%) 
Urinary tract infection  1  1/64 (1.56%)  2/63 (3.17%)  2/30 (6.67%)  7/123 (5.69%) 
Nervous system disorders         
Dizziness  1  1/64 (1.56%)  2/63 (3.17%)  3/30 (10.00%)  2/123 (1.63%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Allergan plc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01678924    
Other Study ID Numbers: 214868-007
2012-002240-24 ( EudraCT Number )
First Submitted: August 31, 2012
First Posted: September 5, 2012
Results First Submitted: August 2, 2016
Results First Posted: January 7, 2020
Last Update Posted: January 7, 2020