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

Study Overview
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Brief Summary
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This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia (PHN).

Conditions
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Neuralgia, Postherpetic

Intervention / Treatment
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* Drug: AGN-214868
* Drug: AGN-214868 Placebo (Vehicle)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGN-214868 Dose 1<br>AGN-214868 Dose 1 given as injections into the area of pain on Day 1. | Drug: AGN-214868<br>* AGN-214868 given as injections into the area of pain on Day 1.<br>|
| Experimental: AGN-214868 Dose 2<br>AGN-214868 Dose 2 given as injections into the area of pain on Day 1. | Drug: AGN-214868<br>* AGN-214868 given as injections into the area of pain on Day 1.<br>|
| Placebo Comparator: AGN-214868 Placebo (Vehicle)<br>AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1. | Drug: AGN-214868 Placebo (Vehicle)<br>* AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.<br>|
| Experimental: AGN-214868 Dose 3<br>AGN-214868 Dose 3 given as injections into the area of pain on Day 1. | Drug: AGN-214868<br>* AGN-214868 given as injections into the area of pain on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Average Pain Intensity Score - Cohort 1 | 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. | Baseline to Week 12 | 
| Change From Baseline in Average Pain Intensity Score - Cohort 2 | 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. | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Average Pain Intensity Score Responders - Cohort 1 - 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 | Baseline to Week 1 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 1 - 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 | Baseline to Week 2 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 1 - 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 | Baseline to Week 3 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 1 - 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 | Baseline to Week 4 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 1 - 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 | Baseline to Week 5 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 1 - 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 | Baseline to Week 6 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 1 - 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 | Baseline to Week 7 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 1 - 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 | Baseline to Week 8 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 1 - 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 | Baseline to Week 9 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 1 - 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 | Baseline to Week 10 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 1 - 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 | Baseline to Week 11 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 1 - 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 | Baseline to Week 12 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 2 - 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 | Baseline to Week 1 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 2 - 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 | Baseline to Week 2 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 2 - 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 | Baseline to Week 3 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 2 - 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 | Baseline to Week 4 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 2 - 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 | Baseline to Week 5 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 2 - 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 | Baseline to Week 6 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 2 - 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 | Baseline to Week 7 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 2 - 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 | Baseline to Week 8 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 2 - 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 | Baseline to Week 9 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 2 - 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 | Baseline to Week 10 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 2 - 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 | Baseline to Week 11 | 
| Percentage of Average Pain Intensity Score Responders - Cohort 2 - 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 | Baseline to Week 12 | 
| Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - 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. | Baseline to Week 2 | 
| Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - 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. | Baseline to Week 4 | 
| Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - 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. | Baseline to Week 8 | 
| Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - 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. | Baseline to Week 12 | 
| Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - 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. | Baseline to Week 2 | 
| Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - 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. | Baseline to Week 4 | 
| Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - 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. | Baseline to Week 8 | 
| Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - 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. | Baseline to Week 12 | 
| Change From Baseline in Area of Allodynia - Cohort 1 - 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. | Baseline to Week 2 | 
| Change From Baseline in Area of Allodynia - Cohort 1 - 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. | Baseline to Week 4 | 
| Change From Baseline in Area of Allodynia - Cohort 1 - 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. | Baseline to Week 8 | 
| Change From Baseline in Area of Allodynia - Cohort 1 - 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. | Baseline to Week 12 | 
| Change From Baseline in Area of Allodynia - Cohort 2 - 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. | Baseline to Week 2 | 
| Change From Baseline in Area of Allodynia - Cohort 2 - 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. | Baseline to Week 4 | 
| Change From Baseline in Area of Allodynia - Cohort 2 - 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. | Baseline to Week 8 | 
| Change From Baseline in Area of Allodynia - Cohort 2 - 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. | Baseline to Week 12 | 
| Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - 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. | Baseline to Week 2 | 
| Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - 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. | Baseline to Week 4 | 
| Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - 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. | Baseline to Week 8 | 
| Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - 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. | Baseline to Week 12 | 
| Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - 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. | Baseline to Week 2 | 
| Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - 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. | Baseline to Week 4 | 
| Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - 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. | Baseline to Week 8 | 
| Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - 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. | Baseline to Week 12 |