| 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. | 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 | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| | | Title | Denominators | Categories |
|---|
| Week 1 | | | Title | Measurements |
|---|
| - OG000-0.88(-1.249 to -0.538)
- OG001-1.02(-1.380 to -0.587)
- OG002-1.11(-1.425 to -0.808)
|
| | Week 2 |
| |
| 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. | 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 | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 1 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 3 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 5 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 7 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 9 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 10 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 11 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 1 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 3 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 5 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 7 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 9 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 10 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 11 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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 | 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 | Posted | | Number | | percentage of patients | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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. | 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 | Posted | | Least Squares Mean | 95% Confidence Interval | Square Centimeters (cm^2) | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
|
| 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. | 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 | Posted | | Least Squares Mean | 95% Confidence Interval | Square Centimeters (cm^2) | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
|
| 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. | 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 | Posted | | Least Squares Mean | 95% Confidence Interval | Square Centimeters (cm^2) | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
|
| 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. | 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 | Posted | | Least Squares Mean | 95% Confidence Interval | Square Centimeters (cm^2) | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
|
| 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. | 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 | Posted | | Least Squares Mean | 95% Confidence Interval | Square Centimeters (cm^2) | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | Square Centimeters (cm^2) | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | Square Centimeters (cm^2) | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | Square Centimeters (cm^2) | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | Square Centimeters (cm^2) | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
|
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | Square Centimeters (cm^2) | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
|
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | Square Centimeters (cm^2) | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
|
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | Square Centimeters (cm^2) | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
|
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | Square Centimeters (cm^2) | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | Square Centimeters (cm^2) | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | Square Centimeters (cm^2) | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | Square Centimeters (cm^2) | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
|
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
|
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
|
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 65µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | AGN 214868 32.5µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG002 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
|
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |
| 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | AGN 214868 130µg | Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1 | | OG001 | Placebo | Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1 |
| |