This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia (PHN).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
280
AGN-214868 given as injections into the area of pain on Day 1.
AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.
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.
Time frame: 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.
Time frame: Baseline to Week 12
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
Time frame: 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
Time frame: Baseline to Week 2
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3
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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
...and 59 more locations
Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline
Time frame: Baseline to Week 3
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 12