A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia
- Conditions
- Neuralgia, Postherpetic
- Interventions
- Drug: AGN-214868 Placebo (Vehicle)
- Registration Number
- NCT01678924
- Lead Sponsor
- Allergan
- Brief Summary
This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia (PHN).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 280
- Postherpetic neuralgia with pain present for at least 9 months
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AGN-214868 Dose 2 AGN-214868 AGN-214868 Dose 2 given as injections into the area of pain on Day 1. AGN-214868 Placebo (Vehicle) AGN-214868 Placebo (Vehicle) AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1. AGN-214868 Dose 3 AGN-214868 AGN-214868 Dose 3 given as injections into the area of pain on Day 1. AGN-214868 Dose 1 AGN-214868 AGN-214868 Dose 1 given as injections into the area of pain on Day 1.
- Primary Outcome Measures
Name Time Method Change From Baseline in Average Pain Intensity Score - Cohort 1 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 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.
- Secondary Outcome Measures
Name Time Method Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1 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 3 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 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 2 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 9 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 2 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 4 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 1 - Week 5 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 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 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 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 10 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 1 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 3 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 11 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 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 12 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 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 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.
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5 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 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 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 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 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 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 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
Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12 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 8 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.
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12 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 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 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 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 Area of Allodynia - Cohort 2 - Week 8 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 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 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 Maximal Area of Spontaneous Pain - Cohort 2 - Week 8 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 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 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 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 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 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 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 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 Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4 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 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 4 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 12 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 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.
Trial Locations
- Locations (68)
Agave Clinical Research, LLC
🇺🇸Mesa, Arizona, United States
Territory Neurology & Research Institute
🇺🇸Tucson, Arizona, United States
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
University of California, Irvine
🇺🇸Irvine, California, United States
Loma Linda University
🇺🇸Loma Linda, California, United States
Northern California Research Corp
🇺🇸Sacramento, California, United States
Neurological Research Institute
🇺🇸Santa Monica, California, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
The Mile High Research Center
🇺🇸Denver, Colorado, United States
Riverside Clinical Research
🇺🇸Edgewater, Florida, United States
Scroll for more (58 remaining)Agave Clinical Research, LLC🇺🇸Mesa, Arizona, United States