Neuralgia, Postherpetic
Conditions
Brief summary
This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia (PHN).
Interventions
DRUGAGN-214868
AGN-214868 given as injections into the area of pain on Day 1.
DRUGAGN-214868 Placebo (Vehicle)
AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Postherpetic neuralgia with pain present for at least 9 months
Exclusion criteria
* Active herpes zoster skin rash * Anticipated treatment for postherpetic neuralgia during the first 3 months of the study, including oral and topical medications, acupuncture, spinal cord stimulation, transcutaneous nerve stimulation (TNS), or trigger point injection * Anticipated treatment with pain medication for the treatment of postherpetic neuralgia during the first 3 months of the study * Use of capsaicin treatment for postherpetic neuralgia within 6 months, or anticipated use during the first 3 months of the study * Use of botulinum toxin of any serotype for any reason within 6 months, or anticipated use during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 |
| 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 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 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 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 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 |
| 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 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. |
| 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 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 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. |
| 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 |
| 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. |
| 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 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 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 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. |
| 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 |
Countries
Austria, Germany, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AGN 214868 130µg Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | 64 |
| AGN 214868 65µg Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | 63 |
| AGN 214868 32.5µg Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | 30 |
| Placebo Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 | 123 |
| Total | 280 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 | 1 |
| Overall Study | Lack of Efficacy | 7 | 2 | 0 | 5 |
| Overall Study | Lost to Follow-up | 0 | 4 | 0 | 2 |
| Overall Study | Personal Reasons | 2 | 2 | 2 | 7 |
| Overall Study | Unable to attend scheduled visits | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Placebo | AGN 214868 65µg | AGN 214868 130µg | AGN 214868 32.5µg |
|---|---|---|---|---|---|
| Age, Continuous | 66.3 years STANDARD_DEVIATION 10.28 | 67.0 years STANDARD_DEVIATION 8.13 | 65.3 years STANDARD_DEVIATION 12.82 | 66.6 years STANDARD_DEVIATION 10.47 | 65.0 years STANDARD_DEVIATION 11.99 |
| Age, Customized 18 years to less than 40 years | 5 participants | 0 participants | 3 participants | 1 participants | 1 participants |
| Age, Customized 40 years to less than 65 years | 97 participants | 46 participants | 19 participants | 20 participants | 12 participants |
| Age, Customized 65 years and over | 178 participants | 77 participants | 41 participants | 43 participants | 17 participants |
| Height | 167.7 cm STANDARD_DEVIATION 9.83 | 166.4 cm STANDARD_DEVIATION 9.07 | 167.7 cm STANDARD_DEVIATION 10.98 | 169.8 cm STANDARD_DEVIATION 10.22 | 169.1 cm STANDARD_DEVIATION 8.91 |
| Race/Ethnicity, Customized Asian | 5 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 15 Participants | 7 Participants | 4 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 246 Participants | 112 Participants | 52 Participants | 56 Participants | 26 Participants |
| Race/Ethnicity, Customized Hispanic | 12 Participants | 2 Participants | 4 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Female | 146 Participants | 73 Participants | 29 Participants | 27 Participants | 17 Participants |
| Sex/Gender, Customized Male | 134 Participants | 50 Participants | 34 Participants | 37 Participants | 13 Participants |
| Weight | 81.1 kg STANDARD_DEVIATION 17.86 | 78.8 kg STANDARD_DEVIATION 17.83 | 82.3 kg STANDARD_DEVIATION 17.67 | 84.9 kg STANDARD_DEVIATION 19.15 | 80.0 kg STANDARD_DEVIATION 14.48 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 64 | 15 / 63 | 8 / 30 | 30 / 123 |
| serious Total, serious adverse events | 2 / 64 | 8 / 63 | 2 / 30 | 10 / 123 |
Outcome results
Primary
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
Population: Two cohorts of patients with postherpetic neuralgia (PHN) were randomized to receive 1 treatment of either AGN-214868 (cohort 1: 32.5 or 65 μg; cohort 2: 130 μg) or placebo. Cohort 1 includes 154 patients from the modified intent to treat (mITT) population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 1 | -0.88 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 2 | -1.33 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 3 | -1.66 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 4 | -1.78 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 5 | -1.83 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 6 | -1.97 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 7 | -2.00 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 8 | -2.11 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 9 | -2.21 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 10 | -2.28 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 11 | -2.27 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 12 | -2.20 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 12 | -2.53 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 1 | -1.02 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 7 | -2.08 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 9 | -2.15 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 2 | -1.56 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 6 | -2.07 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 11 | -2.46 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 3 | -1.93 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 8 | -2.02 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 5 | -2.19 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 4 | -2.20 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 10 | -2.29 units on a scale |
| Placebo | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 4 | -1.98 units on a scale |
| Placebo | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 5 | -2.10 units on a scale |
| Placebo | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 10 | -2.48 units on a scale |
| Placebo | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 6 | -2.34 units on a scale |
| Placebo | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 7 | -2.32 units on a scale |
| Placebo | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 8 | -2.40 units on a scale |
| Placebo | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 11 | -2.56 units on a scale |
| Placebo | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 1 | -1.11 units on a scale |
| Placebo | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 2 | -1.57 units on a scale |
| Placebo | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 9 | -2.52 units on a scale |
| Placebo | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 3 | -1.84 units on a scale |
| Placebo | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Week 12 | -2.65 units on a scale |
Primary
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
Population: Two cohorts of patients with postherpetic neuralgia (PHN) were randomized to receive 1 treatment of either AGN-214868 (cohort 1: 32.5 or 65 μg; cohort 2: 130 μg) or placebo. Cohort 2 includes 125 patients from the mITT population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 1 | -0.78 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 2 | -1.12 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 3 | -1.45 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 4 | -1.62 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 5 | -1.88 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 6 | -2.04 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 7 | -2.14 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 8 | -2.29 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 9 | -2.35 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 10 | -2.44 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 11 | -2.49 units on a scale |
| AGN 214868 65µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 12 | -2.49 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 11 | -2.03 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 1 | -0.88 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 7 | -1.90 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 2 | -1.37 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 10 | -2.04 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 3 | -1.65 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 8 | -1.96 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 4 | -1.90 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 12 | -2.03 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 5 | -1.88 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 9 | -2.00 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Week 6 | -1.90 units on a scale |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Area of Allodynia - Cohort 1 - Week 12 | -67.71 Square Centimeters (cm^2) |
| AGN 214868 32.5µg | Change From Baseline in Area of Allodynia - Cohort 1 - Week 12 | -39.96 Square Centimeters (cm^2) |
| Placebo | Change From Baseline in Area of Allodynia - Cohort 1 - Week 12 | -70.46 Square Centimeters (cm^2) |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Area of Allodynia - Cohort 1 - Week 2 | -40.06 Square Centimeters (cm^2) |
| AGN 214868 32.5µg | Change From Baseline in Area of Allodynia - Cohort 1 - Week 2 | -14.42 Square Centimeters (cm^2) |
| Placebo | Change From Baseline in Area of Allodynia - Cohort 1 - Week 2 | -52.73 Square Centimeters (cm^2) |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Area of Allodynia - Cohort 1 - Week 4 | -54.12 Square Centimeters (cm^2) |
| AGN 214868 32.5µg | Change From Baseline in Area of Allodynia - Cohort 1 - Week 4 | -23.07 Square Centimeters (cm^2) |
| Placebo | Change From Baseline in Area of Allodynia - Cohort 1 - Week 4 | -58.14 Square Centimeters (cm^2) |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Area of Allodynia - Cohort 1 - Week 8 | -74.46 Square Centimeters (cm^2) |
| AGN 214868 32.5µg | Change From Baseline in Area of Allodynia - Cohort 1 - Week 8 | -50.47 Square Centimeters (cm^2) |
| Placebo | Change From Baseline in Area of Allodynia - Cohort 1 - Week 8 | -71.54 Square Centimeters (cm^2) |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Area of Allodynia - Cohort 2 - Week 12 | -77.98 Square Centimeters (cm^2) |
| AGN 214868 32.5µg | Change From Baseline in Area of Allodynia - Cohort 2 - Week 12 | -79.99 Square Centimeters (cm^2) |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Area of Allodynia - Cohort 2 - Week 2 | -36.66 Square Centimeters (cm^2) |
| AGN 214868 32.5µg | Change From Baseline in Area of Allodynia - Cohort 2 - Week 2 | -60.71 Square Centimeters (cm^2) |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Area of Allodynia - Cohort 2 - Week 4 | -54.33 Square Centimeters (cm^2) |
| AGN 214868 32.5µg | Change From Baseline in Area of Allodynia - Cohort 2 - Week 4 | -69.39 Square Centimeters (cm^2) |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Area of Allodynia - Cohort 2 - Week 8 | -78.78 Square Centimeters (cm^2) |
| AGN 214868 32.5µg | Change From Baseline in Area of Allodynia - Cohort 2 - Week 8 | -75.58 Square Centimeters (cm^2) |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12 | -19.2 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12 | -21.6 units on a scale |
| Placebo | Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12 | -21.5 units on a scale |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2 | -17.4 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2 | -21.2 units on a scale |
| Placebo | Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2 | -15.3 units on a scale |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4 | -21.9 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4 | -20.5 units on a scale |
| Placebo | Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4 | -12.3 units on a scale |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8 | -22.7 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8 | -24.8 units on a scale |
| Placebo | Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8 | -19.4 units on a scale |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 12 | -26.9 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 12 | -19.1 units on a scale |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 2 | -19.0 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 2 | -16.2 units on a scale |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 4 | -20.6 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 4 | -20.5 units on a scale |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 8 | -28.7 units on a scale |
| AGN 214868 32.5µg | Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 8 | -19.7 units on a scale |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12 | -30.99 Square Centimeters (cm^2) |
| AGN 214868 32.5µg | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12 | -31.40 Square Centimeters (cm^2) |
| Placebo | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12 | -35.03 Square Centimeters (cm^2) |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2 | -25.07 Square Centimeters (cm^2) |
| AGN 214868 32.5µg | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2 | -34.07 Square Centimeters (cm^2) |
| Placebo | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2 | -26.10 Square Centimeters (cm^2) |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4 | -27.65 Square Centimeters (cm^2) |
| AGN 214868 32.5µg | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4 | -25.96 Square Centimeters (cm^2) |
| Placebo | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4 | -32.23 Square Centimeters (cm^2) |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8 | -29.86 Square Centimeters (cm^2) |
| AGN 214868 32.5µg | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8 | -37.18 Square Centimeters (cm^2) |
| Placebo | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8 | -34.04 Square Centimeters (cm^2) |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12 | -36.73 Square Centimeters (cm^2) |
| AGN 214868 32.5µg | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12 | -32.60 Square Centimeters (cm^2) |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2 | -9.86 Square Centimeters (cm^2) |
| AGN 214868 32.5µg | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2 | -27.52 Square Centimeters (cm^2) |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4 | -22.23 Square Centimeters (cm^2) |
| AGN 214868 32.5µg | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4 | -25.67 Square Centimeters (cm^2) |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AGN 214868 65µg | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8 | -42.92 Square Centimeters (cm^2) |
| AGN 214868 32.5µg | Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8 | -31.95 Square Centimeters (cm^2) |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1 | 18.0 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1 | 33.3 percentage of patients |
| Placebo | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1 | 21.3 percentage of patients |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10 | 46.4 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10 | 53.6 percentage of patients |
| Placebo | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10 | 55.8 percentage of patients |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11 | 47.2 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11 | 53.6 percentage of patients |
| Placebo | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11 | 59.6 percentage of patients |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12 | 48.0 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12 | 63.0 percentage of patients |
| Placebo | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12 | 63.3 percentage of patients |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2 | 27.0 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2 | 40.0 percentage of patients |
| Placebo | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2 | 36.7 percentage of patients |
Secondary
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
Time frame: Baseline to Week 3
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3 | 35.0 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3 | 50.0 percentage of patients |
| Placebo | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3 | 50.0 percentage of patients |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4 | 37.7 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4 | 53.3 percentage of patients |
| Placebo | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4 | 50.8 percentage of patients |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5 | 40.7 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5 | 53.3 percentage of patients |
| Placebo | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5 | 52.6 percentage of patients |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6 | 41.4 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6 | 50.0 percentage of patients |
| Placebo | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6 | 54.5 percentage of patients |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7 | 43.3 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7 | 56.7 percentage of patients |
| Placebo | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7 | 50.9 percentage of patients |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8 | 43.1 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8 | 50.0 percentage of patients |
| Placebo | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8 | 55.4 percentage of patients |
Secondary
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
Population: The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9 | 43.6 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9 | 51.9 percentage of patients |
| Placebo | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9 | 51.9 percentage of patients |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1 | 14.3 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1 | 20.3 percentage of patients |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10 | 64.7 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10 | 47.3 percentage of patients |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11 | 64.0 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11 | 42.6 percentage of patients |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12 | 61.4 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12 | 40.0 percentage of patients |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2 | 25.8 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2 | 27.6 percentage of patients |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3 | 30.5 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3 | 39.7 percentage of patients |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4 | 35.0 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4 | 43.1 percentage of patients |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5 | 42.1 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5 | 45.6 percentage of patients |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6 | 45.3 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6 | 45.6 percentage of patients |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7 | 50.0 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7 | 48.2 percentage of patients |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8 | 54.9 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8 | 49.1 percentage of patients |
Secondary
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
Population: The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN 214868 65µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9 | 58.8 percentage of patients |
| AGN 214868 32.5µg | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9 | 45.5 percentage of patients |