A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01678924 |
Recruitment Status :
Terminated
First Posted : September 5, 2012
Results First Posted : January 7, 2020
Last Update Posted : January 7, 2020
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuralgia, Postherpetic | Drug: AGN-214868 Drug: AGN-214868 Placebo (Vehicle) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 280 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | May 2015 |
Actual Study Completion Date : | September 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: AGN-214868 Dose 1
AGN-214868 Dose 1 given as injections into the area of pain on Day 1.
|
Drug: AGN-214868
AGN-214868 given as injections into the area of pain on Day 1. |
Experimental: AGN-214868 Dose 2
AGN-214868 Dose 2 given as injections into the area of pain on Day 1.
|
Drug: AGN-214868
AGN-214868 given as injections into the area of pain on Day 1. |
Placebo Comparator: AGN-214868 Placebo (Vehicle)
AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.
|
Drug: AGN-214868 Placebo (Vehicle)
AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1. |
Experimental: AGN-214868 Dose 3
AGN-214868 Dose 3 given as injections into the area of pain on Day 1.
|
Drug: AGN-214868
AGN-214868 given as injections into the area of pain on Day 1. |
- Change From Baseline in Average Pain Intensity Score - Cohort 1 [ Time Frame: Baseline to Week 12 ]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.
- Change From Baseline in Average Pain Intensity Score - Cohort 2 [ Time Frame: Baseline to Week 12 ]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.
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1 [ Time Frame: Baseline to Week 1 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2 [ Time Frame: Baseline to Week 2 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3 [ Time Frame: Baseline to Week 3 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4 [ Time Frame: Baseline to Week 4 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5 [ Time Frame: Baseline to Week 5 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6 [ Time Frame: Baseline to Week 6 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7 [ Time Frame: Baseline to Week 7 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8 [ Time Frame: Baseline to Week 8 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9 [ Time Frame: Baseline to Week 9 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10 [ Time Frame: Baseline to Week 10 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11 [ Time Frame: Baseline to Week 11 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12 [ Time Frame: Baseline to Week 12 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1 [ Time Frame: Baseline to Week 1 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2 [ Time Frame: Baseline to Week 2 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3 [ Time Frame: Baseline to Week 3 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4 [ Time Frame: Baseline to Week 4 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5 [ Time Frame: Baseline to Week 5 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6 [ Time Frame: Baseline to Week 6 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7 [ Time Frame: Baseline to Week 7 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8 [ Time Frame: Baseline to Week 8 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9 [ Time Frame: Baseline to Week 9 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10 [ Time Frame: Baseline to Week 10 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11 [ Time Frame: Baseline to Week 11 ]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
- Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12 [ Time Frame: Baseline to Week 12 ]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
- Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2 [ Time Frame: Baseline to Week 2 ]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.
- Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4 [ Time Frame: Baseline to Week 4 ]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.
- Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8 [ Time Frame: Baseline to Week 8 ]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.
- Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12 [ Time Frame: Baseline to Week 12 ]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.
- Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2 [ Time Frame: Baseline to Week 2 ]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.
- Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4 [ Time Frame: Baseline to Week 4 ]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.
- Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8 [ Time Frame: Baseline to Week 8 ]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.
- Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12 [ Time Frame: Baseline to Week 12 ]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.
- Change From Baseline in Area of Allodynia - Cohort 1 - Week 2 [ Time Frame: Baseline to Week 2 ]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.
- Change From Baseline in Area of Allodynia - Cohort 1 - Week 4 [ Time Frame: Baseline to Week 4 ]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.
- Change From Baseline in Area of Allodynia - Cohort 1 - Week 8 [ Time Frame: Baseline to Week 8 ]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.
- Change From Baseline in Area of Allodynia - Cohort 1 - Week 12 [ Time Frame: Baseline to Week 12 ]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.
- Change From Baseline in Area of Allodynia - Cohort 2 - Week 2 [ Time Frame: Baseline to Week 2 ]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.
- Change From Baseline in Area of Allodynia - Cohort 2 - Week 4 [ Time Frame: Baseline to Week 4 ]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.
- Change From Baseline in Area of Allodynia - Cohort 2 - Week 8 [ Time Frame: Baseline to Week 8 ]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.
- Change From Baseline in Area of Allodynia - Cohort 2 - Week 12 [ Time Frame: Baseline to Week 12 ]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.
- Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2 [ Time Frame: Baseline to Week 2 ]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.
- Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4 [ Time Frame: Baseline to Week 4 ]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.
- Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8 [ Time Frame: Baseline to Week 8 ]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.
- Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12 [ Time Frame: Baseline to Week 12 ]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.
- Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 2 [ Time Frame: Baseline to Week 2 ]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.
- Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 4 [ Time Frame: Baseline to Week 4 ]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.
- Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 8 [ Time Frame: Baseline to Week 8 ]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.
- Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 12 [ Time Frame: Baseline to Week 12 ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Postherpetic neuralgia with pain present for at least 9 months
Exclusion Criteria:
- Active herpes zoster skin rash
- Anticipated treatment for postherpetic neuralgia during the first 3 months of the study, including oral and topical medications, acupuncture, spinal cord stimulation, transcutaneous nerve stimulation (TNS), or trigger point injection
- Anticipated treatment with pain medication for the treatment of postherpetic neuralgia during the first 3 months of the study
- Use of capsaicin treatment for postherpetic neuralgia within 6 months, or anticipated use during the first 3 months of the study
- Use of botulinum toxin of any serotype for any reason within 6 months, or anticipated use during the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678924

Study Director: | Medical Director | Allergan |
Responsible Party: | Allergan |
ClinicalTrials.gov Identifier: | NCT01678924 |
Other Study ID Numbers: |
214868-007 2012-002240-24 ( EudraCT Number ) |
First Posted: | September 5, 2012 Key Record Dates |
Results First Posted: | January 7, 2020 |
Last Update Posted: | January 7, 2020 |
Last Verified: | December 2019 |
Neuralgia Neuralgia, Postherpetic Peripheral Nervous System Diseases Neuromuscular Diseases |
Nervous System Diseases Pain Neurologic Manifestations |