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

• 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: Allergan
• Information provided by (Responsible Party): Allergan

Tracking Information

• First Submitted Date: August 31, 2012
• First Posted Date: September 5, 2012
• Results First Submitted Date: August 2, 2016
• Results First Posted Date: January 7, 2020
• Last Update Posted Date: January 7, 2020
• Study Start Date: January 2013
• Actual Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 19, 2019)

• 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.

• Original Primary Outcome Measures (submitted: August 31, 2012): Change from Baseline in Average Pain Intensity Score [ Time Frame: Baseline, Week 12 ]

Current Secondary Outcome Measures (submitted: December 19, 2019)

• 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.

Original Secondary Outcome Measures (submitted: August 31, 2012)

• Percentage of Average Pain Intensity Score Responders [ Time Frame: Week 12 ]
• Change from Baseline in Maximal Area of Spontaneous Pain [ Time Frame: Baseline, 12 Weeks ]
• Change from Baseline in Area of Allodynia [ Time Frame: Baseline, 12 Weeks ]
• Change from Baseline in Evoked Pain Score in the Area of Allodynia [ Time Frame: Baseline, 12 Weeks ]
• Change from Baseline in Average Pain Intensity Score [ Time Frame: Baseline, 8 Weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia
• Official Title: Not Provided
• Brief Summary: This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia (PHN).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Neuralgia, Postherpetic

Intervention

• Drug: AGN-214868
  AGN-214868 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.

Study Arms

• Experimental: AGN-214868 Dose 1
  AGN-214868 Dose 1 given as injections into the area of pain on Day 1.
  Intervention: Drug: AGN-214868
• Experimental: AGN-214868 Dose 2
  AGN-214868 Dose 2 given as injections into the area of pain on Day 1.
  Intervention: Drug: AGN-214868
• Placebo Comparator: AGN-214868 Placebo (Vehicle)
  AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.
  Intervention: Drug: AGN-214868 Placebo (Vehicle)
• Experimental: AGN-214868 Dose 3
  AGN-214868 Dose 3 given as injections into the area of pain on Day 1.
  Intervention: Drug: AGN-214868

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 19, 2019): 280
• Original Estimated Enrollment (submitted: August 31, 2012): 342
• Actual Study Completion Date: September 2015
• Actual Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Germany, Poland, United States
• Removed Location Countries: Australia, Czech Republic

Administrative Information

• NCT Number: NCT01678924
• Other Study ID Numbers: 214868-007; 2012-002240-24 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Allergan
• Study Sponsor: Allergan
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Allergan

• PRS Account: Allergan
• Verification Date: December 2019