Trial Outcomes & Findings for A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia (NCT NCT01678924)
NCT ID: NCT01678924
Last Updated: 2020-01-07
Results Overview
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.
TERMINATED
PHASE2
280 participants
Baseline to Week 12
2020-01-07
Participant Flow
Participant milestones
| Measure |
AGN 214868 130µg
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 65µg
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
64
|
63
|
30
|
123
|
|
Overall Study
COMPLETED
|
54
|
51
|
28
|
105
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
2
|
18
|
Reasons for withdrawal
| Measure |
AGN 214868 130µg
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 65µg
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|---|
|
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
Withdrawal by Subject
|
0
|
3
|
0
|
2
|
|
Overall Study
Unable to attend scheduled visits
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia
Baseline characteristics by cohort
| Measure |
AGN 214868 130µg
n=64 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 65µg
n=63 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=30 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=123 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Weight
|
84.9 kg
STANDARD_DEVIATION 19.15 • n=5 Participants
|
82.3 kg
STANDARD_DEVIATION 17.67 • n=7 Participants
|
80.0 kg
STANDARD_DEVIATION 14.48 • n=5 Participants
|
78.8 kg
STANDARD_DEVIATION 17.83 • n=4 Participants
|
81.1 kg
STANDARD_DEVIATION 17.86 • n=21 Participants
|
|
Height
|
169.8 cm
STANDARD_DEVIATION 10.22 • n=5 Participants
|
167.7 cm
STANDARD_DEVIATION 10.98 • n=7 Participants
|
169.1 cm
STANDARD_DEVIATION 8.91 • n=5 Participants
|
166.4 cm
STANDARD_DEVIATION 9.07 • n=4 Participants
|
167.7 cm
STANDARD_DEVIATION 9.83 • n=21 Participants
|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 10.47 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 12.82 • n=7 Participants
|
65.0 years
STANDARD_DEVIATION 11.99 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 8.13 • n=4 Participants
|
66.3 years
STANDARD_DEVIATION 10.28 • n=21 Participants
|
|
Age, Customized
18 years to less than 40 years
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Age, Customized
40 years to less than 65 years
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
12 participants
n=5 Participants
|
46 participants
n=4 Participants
|
97 participants
n=21 Participants
|
|
Age, Customized
65 years and over
|
43 participants
n=5 Participants
|
41 participants
n=7 Participants
|
17 participants
n=5 Participants
|
77 participants
n=4 Participants
|
178 participants
n=21 Participants
|
|
Sex/Gender, Customized
Male
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
134 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Female
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
146 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
56 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
246 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: 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
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=63 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=30 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=61 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Average Pain Intensity Score - Cohort 1
Week 1
|
-0.88 units on a scale
Interval -1.249 to -0.538
|
-1.02 units on a scale
Interval -1.38 to -0.587
|
-1.11 units on a scale
Interval -1.425 to -0.808
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 1
Week 2
|
-1.33 units on a scale
Interval -1.746 to -0.968
|
-1.56 units on a scale
Interval -1.963 to -1.017
|
-1.57 units on a scale
Interval -1.97 to -1.174
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 1
Week 3
|
-1.66 units on a scale
Interval -2.143 to -1.203
|
-1.93 units on a scale
Interval -2.426 to -1.227
|
-1.84 units on a scale
Interval -2.248 to -1.388
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 1
Week 4
|
-1.78 units on a scale
Interval -2.277 to -1.31
|
-2.20 units on a scale
Interval -2.721 to -1.432
|
-1.98 units on a scale
Interval -2.423 to -1.482
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 1
Week 5
|
-1.83 units on a scale
Interval -2.321 to -1.384
|
-2.19 units on a scale
Interval -2.675 to -1.379
|
-2.10 units on a scale
Interval -2.557 to -1.554
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 1
Week 6
|
-1.97 units on a scale
Interval -2.442 to -1.495
|
-2.07 units on a scale
Interval -2.597 to -1.297
|
-2.34 units on a scale
Interval -2.755 to -1.697
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 1
Week 7
|
-2.00 units on a scale
Interval -2.481 to -1.506
|
-2.08 units on a scale
Interval -2.572 to -1.328
|
-2.32 units on a scale
Interval -2.746 to -1.673
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 1
Week 8
|
-2.11 units on a scale
Interval -2.591 to -1.618
|
-2.02 units on a scale
Interval -2.53 to -1.263
|
-2.40 units on a scale
Interval -2.825 to -1.745
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 1
Week 9
|
-2.21 units on a scale
Interval -2.66 to -1.701
|
-2.15 units on a scale
Interval -2.682 to -1.352
|
-2.52 units on a scale
Interval -2.805 to -1.733
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 1
Week 10
|
-2.28 units on a scale
Interval -2.679 to -1.674
|
-2.29 units on a scale
Interval -2.812 to -1.481
|
-2.48 units on a scale
Interval -2.743 to -1.634
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 1
Week 11
|
-2.27 units on a scale
Interval -2.684 to -1.672
|
-2.46 units on a scale
Interval -2.996 to -1.57
|
-2.56 units on a scale
Interval -2.807 to -1.724
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 1
Week 12
|
-2.20 units on a scale
Interval -2.626 to -1.6
|
-2.53 units on a scale
Interval -3.061 to -1.605
|
-2.65 units on a scale
Interval -2.886 to -1.783
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: 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
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=64 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=61 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Average Pain Intensity Score - Cohort 2
Week 1
|
-0.78 units on a scale
Interval -1.093 to -0.451
|
-0.88 units on a scale
Interval -1.19 to -0.492
|
—
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 2
Week 2
|
-1.12 units on a scale
Interval -1.508 to -0.701
|
-1.37 units on a scale
Interval -1.791 to -0.799
|
—
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 2
Week 3
|
-1.45 units on a scale
Interval -1.788 to -0.952
|
-1.65 units on a scale
Interval -2.064 to -1.057
|
—
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 2
Week 4
|
-1.62 units on a scale
Interval -1.934 to -1.072
|
-1.90 units on a scale
Interval -2.344 to -1.269
|
—
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 2
Week 5
|
-1.88 units on a scale
Interval -2.202 to -1.301
|
-1.88 units on a scale
Interval -2.366 to -1.257
|
—
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 2
Week 6
|
-2.04 units on a scale
Interval -2.226 to -1.305
|
-1.90 units on a scale
Interval -2.339 to -1.235
|
—
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 2
Week 7
|
-2.14 units on a scale
Interval -2.345 to -1.352
|
-1.90 units on a scale
Interval -2.352 to -1.225
|
—
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 2
Week 8
|
-2.29 units on a scale
Interval -2.405 to -1.404
|
-1.96 units on a scale
Interval -2.412 to -1.27
|
—
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 2
Week 9
|
-2.35 units on a scale
Interval -2.493 to -1.497
|
-2.00 units on a scale
Interval -2.457 to -1.293
|
—
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 2
Week 10
|
-2.44 units on a scale
Interval -2.584 to -1.557
|
-2.04 units on a scale
Interval -2.515 to -1.311
|
—
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 2
Week 11
|
-2.49 units on a scale
Interval -2.647 to -1.581
|
-2.03 units on a scale
Interval -2.489 to -1.314
|
—
|
|
Change From Baseline in Average Pain Intensity Score - Cohort 2
Week 12
|
-2.49 units on a scale
Interval -2.659 to -1.632
|
-2.03 units on a scale
Interval -2.538 to -1.354
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 1Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=61 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=30 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=61 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1
|
18.0 percentage of patients
|
33.3 percentage of patients
|
21.3 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to Week 2Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=63 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=30 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=60 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2
|
27.0 percentage of patients
|
40.0 percentage of patients
|
36.7 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to Week 3Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=60 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=30 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=60 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3
|
35.0 percentage of patients
|
50.0 percentage of patients
|
50.0 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=61 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=30 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=59 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4
|
37.7 percentage of patients
|
53.3 percentage of patients
|
50.8 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to Week 5Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=59 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=30 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=57 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5
|
40.7 percentage of patients
|
53.3 percentage of patients
|
52.6 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=58 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=30 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=55 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6
|
41.4 percentage of patients
|
50.0 percentage of patients
|
54.5 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to Week 7Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=60 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=30 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=57 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7
|
43.3 percentage of patients
|
56.7 percentage of patients
|
50.9 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=58 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=30 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=56 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8
|
43.1 percentage of patients
|
50.0 percentage of patients
|
55.4 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to Week 9Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=55 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=27 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=52 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9
|
43.6 percentage of patients
|
51.9 percentage of patients
|
51.9 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to Week 10Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=56 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=28 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=52 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10
|
46.4 percentage of patients
|
53.6 percentage of patients
|
55.8 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to Week 11Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=53 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=28 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=52 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11
|
47.2 percentage of patients
|
53.6 percentage of patients
|
59.6 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=50 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=27 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=49 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12
|
48.0 percentage of patients
|
63.0 percentage of patients
|
63.3 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to Week 1Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=63 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=59 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1
|
14.3 percentage of patients
|
20.3 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 2Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=62 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=58 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2
|
25.8 percentage of patients
|
27.6 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 3Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=59 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=58 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3
|
30.5 percentage of patients
|
39.7 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=60 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=58 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4
|
35.0 percentage of patients
|
43.1 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 5Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=57 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=57 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5
|
42.1 percentage of patients
|
45.6 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=53 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=57 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6
|
45.3 percentage of patients
|
45.6 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 7Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=50 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=56 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7
|
50.0 percentage of patients
|
48.2 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=51 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=55 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8
|
54.9 percentage of patients
|
49.1 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 9Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=51 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=55 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9
|
58.8 percentage of patients
|
45.5 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 10Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=51 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=55 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10
|
64.7 percentage of patients
|
47.3 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 11Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=50 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=54 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11
|
64.0 percentage of patients
|
42.6 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: 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
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
Outcome measures
| Measure |
AGN 214868 65µg
n=44 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=50 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12
|
61.4 percentage of patients
|
40.0 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 2Population: 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
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=61 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=27 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=60 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2
|
-25.07 Square Centimeters (cm^2)
Interval -37.544 to -13.564
|
-34.07 Square Centimeters (cm^2)
Interval -60.871 to -4.114
|
-26.10 Square Centimeters (cm^2)
Interval -38.58 to -14.053
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: 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
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=62 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=29 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=60 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4
|
-27.65 Square Centimeters (cm^2)
Interval -40.978 to -15.412
|
-25.96 Square Centimeters (cm^2)
Interval -49.316 to 0.309
|
-32.23 Square Centimeters (cm^2)
Interval -48.543 to -16.214
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: 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
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=56 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=28 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=55 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8
|
-29.86 Square Centimeters (cm^2)
Interval -45.876 to -15.566
|
-37.18 Square Centimeters (cm^2)
Interval -64.825 to -1.989
|
-34.04 Square Centimeters (cm^2)
Interval -48.026 to -22.134
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: 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
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=57 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=29 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=54 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12
|
-30.99 Square Centimeters (cm^2)
Interval -46.118 to -17.138
|
-31.40 Square Centimeters (cm^2)
Interval -61.185 to 3.853
|
-35.03 Square Centimeters (cm^2)
Interval -53.242 to -18.425
|
SECONDARY outcome
Timeframe: Baseline to Week 2Population: 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
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=57 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=57 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2
|
-9.86 Square Centimeters (cm^2)
Interval -38.087 to 18.02
|
-27.52 Square Centimeters (cm^2)
Interval -43.841 to -10.854
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=58 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=59 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4
|
-22.23 Square Centimeters (cm^2)
Interval -48.893 to 3.903
|
-25.67 Square Centimeters (cm^2)
Interval -42.901 to -7.909
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=53 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=57 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8
|
-42.92 Square Centimeters (cm^2)
Interval -65.58 to -23.08
|
-31.95 Square Centimeters (cm^2)
Interval -47.299 to -13.978
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=54 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=57 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12
|
-36.73 Square Centimeters (cm^2)
Interval -67.719 to -8.696
|
-32.60 Square Centimeters (cm^2)
Interval -49.823 to -12.574
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 2Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=61 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=27 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=60 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Area of Allodynia - Cohort 1 - Week 2
|
-40.06 Square Centimeters (cm^2)
Interval -89.75 to -12.158
|
-14.42 Square Centimeters (cm^2)
Interval -34.431 to 23.824
|
-52.73 Square Centimeters (cm^2)
Interval -67.258 to -24.248
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=62 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=29 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=60 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Area of Allodynia - Cohort 1 - Week 4
|
-54.12 Square Centimeters (cm^2)
Interval -118.867 to -19.566
|
-23.07 Square Centimeters (cm^2)
Interval -41.985 to 19.468
|
-58.14 Square Centimeters (cm^2)
Interval -70.452 to -26.048
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=56 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=28 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=55 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Area of Allodynia - Cohort 1 - Week 8
|
-74.46 Square Centimeters (cm^2)
Interval -136.541 to -43.526
|
-50.47 Square Centimeters (cm^2)
Interval -75.433 to -4.124
|
-71.54 Square Centimeters (cm^2)
Interval -85.155 to -37.104
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=57 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=29 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=54 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Area of Allodynia - Cohort 1 - Week 12
|
-67.71 Square Centimeters (cm^2)
Interval -130.695 to -35.611
|
-39.96 Square Centimeters (cm^2)
Interval -62.646 to 8.446
|
-70.46 Square Centimeters (cm^2)
Interval -92.167 to -29.97
|
SECONDARY outcome
Timeframe: Baseline to Week 2Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=57 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=57 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Area of Allodynia - Cohort 2 - Week 2
|
-36.66 Square Centimeters (cm^2)
Interval -59.461 to -0.328
|
-60.71 Square Centimeters (cm^2)
Interval -98.564 to -36.369
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=58 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=59 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Area of Allodynia - Cohort 2 - Week 4
|
-54.33 Square Centimeters (cm^2)
Interval -72.041 to -13.677
|
-69.39 Square Centimeters (cm^2)
Interval -116.234 to -45.112
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=53 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=57 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Area of Allodynia - Cohort 2 - Week 8
|
-78.78 Square Centimeters (cm^2)
Interval -99.958 to -43.748
|
-75.58 Square Centimeters (cm^2)
Interval -113.401 to -50.634
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=54 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=57 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Area of Allodynia - Cohort 2 - Week 12
|
-77.98 Square Centimeters (cm^2)
Interval -99.148 to -36.515
|
-79.99 Square Centimeters (cm^2)
Interval -129.775 to -49.428
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 2Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=48 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=21 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=50 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2
|
-17.4 units on a scale
Interval -25.67 to -10.68
|
-21.2 units on a scale
Interval -30.01 to -10.09
|
-15.3 units on a scale
Interval -22.76 to -7.32
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=50 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=25 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=51 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4
|
-21.9 units on a scale
Interval -29.67 to -15.57
|
-20.5 units on a scale
Interval -28.34 to -11.34
|
-12.3 units on a scale
Interval -19.02 to -5.01
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=51 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=22 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=49 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8
|
-22.7 units on a scale
Interval -31.18 to -15.8
|
-24.8 units on a scale
Interval -34.73 to -14.45
|
-19.4 units on a scale
Interval -27.27 to -10.15
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=51 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=23 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=46 Participants
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12
|
-19.2 units on a scale
Interval -27.51 to -12.14
|
-21.6 units on a scale
Interval -33.46 to -9.41
|
-21.5 units on a scale
Interval -28.99 to -12.79
|
SECONDARY outcome
Timeframe: Baseline to Week 2Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=53 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=55 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 2
|
-19.0 units on a scale
Interval -26.102 to -11.03
|
-16.2 units on a scale
Interval -23.4 to -9.691
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=52 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=55 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 4
|
-20.6 units on a scale
Interval -27.941 to -10.867
|
-20.5 units on a scale
Interval -29.487 to -13.64
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=48 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=52 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 8
|
-28.7 units on a scale
Interval -35.924 to -21.285
|
-19.7 units on a scale
Interval -27.721 to -11.895
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: 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.
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.
Outcome measures
| Measure |
AGN 214868 65µg
n=47 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=51 Participants
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|
|
Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 12
|
-26.9 units on a scale
Interval -37.75 to -16.548
|
-19.1 units on a scale
Interval -26.996 to -10.612
|
—
|
Adverse Events
AGN 214868 130µg
AGN 214868 65µg
AGN 214868 32.5µg
Placebo
Serious adverse events
| Measure |
AGN 214868 130µg
n=64 participants at risk
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 65µg
n=63 participants at risk
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=30 participants at risk
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=123 participants at risk
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/64
|
0.00%
0/63
|
0.00%
0/30
|
0.81%
1/123
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/64
|
0.00%
0/63
|
0.00%
0/30
|
0.00%
0/123
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
1/64
|
0.00%
0/63
|
0.00%
0/30
|
0.00%
0/123
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/64
|
1.6%
1/63
|
0.00%
0/30
|
0.00%
0/123
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/64
|
0.00%
0/63
|
0.00%
0/30
|
0.81%
1/123
|
|
General disorders
Oedema peripheral
|
0.00%
0/64
|
0.00%
0/63
|
0.00%
0/30
|
0.81%
1/123
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/64
|
3.2%
2/63
|
0.00%
0/30
|
0.00%
0/123
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/64
|
1.6%
1/63
|
0.00%
0/30
|
0.00%
0/123
|
|
Infections and infestations
Erysipelas
|
0.00%
0/64
|
0.00%
0/63
|
0.00%
0/30
|
0.81%
1/123
|
|
Infections and infestations
Furuncle
|
0.00%
0/64
|
0.00%
0/63
|
0.00%
0/30
|
0.81%
1/123
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/64
|
0.00%
0/63
|
0.00%
0/30
|
0.81%
1/123
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/64
|
0.00%
0/63
|
0.00%
0/30
|
0.81%
1/123
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/64
|
0.00%
0/63
|
0.00%
0/30
|
0.81%
1/123
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/64
|
0.00%
0/63
|
0.00%
0/30
|
0.81%
1/123
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.00%
0/64
|
0.00%
0/63
|
0.00%
0/30
|
0.81%
1/123
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
0.00%
0/64
|
0.00%
0/63
|
0.00%
0/30
|
0.81%
1/123
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/64
|
0.00%
0/63
|
0.00%
0/30
|
0.81%
1/123
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/64
|
1.6%
1/63
|
3.3%
1/30
|
0.00%
0/123
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/64
|
1.6%
1/63
|
0.00%
0/30
|
0.81%
1/123
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/64
|
1.6%
1/63
|
0.00%
0/30
|
0.00%
0/123
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/64
|
0.00%
0/63
|
3.3%
1/30
|
0.00%
0/123
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/64
|
0.00%
0/63
|
3.3%
1/30
|
0.00%
0/123
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/64
|
1.6%
1/63
|
0.00%
0/30
|
0.00%
0/123
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/64
|
0.00%
0/63
|
0.00%
0/30
|
0.81%
1/123
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/64
|
0.00%
0/63
|
0.00%
0/30
|
0.81%
1/123
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/64
|
0.00%
0/63
|
0.00%
0/30
|
0.81%
1/123
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/64
|
1.6%
1/63
|
0.00%
0/30
|
0.81%
1/123
|
Other adverse events
| Measure |
AGN 214868 130µg
n=64 participants at risk
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 65µg
n=63 participants at risk
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
AGN 214868 32.5µg
n=30 participants at risk
Single administration of AGN-214868, total dose given as injections into the area of pain on Day 1
|
Placebo
n=123 participants at risk
Single administration of AGN-214868 placebo, given as injections into the area of pain on Day 1
|
|---|---|---|---|---|
|
General disorders
Injection site pain
|
9.4%
6/64
|
1.6%
1/63
|
0.00%
0/30
|
4.9%
6/123
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
4/64
|
7.9%
5/63
|
3.3%
1/30
|
6.5%
8/123
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
3/64
|
7.9%
5/63
|
6.7%
2/30
|
7.3%
9/123
|
|
Nervous system disorders
Dizziness
|
1.6%
1/64
|
3.2%
2/63
|
10.0%
3/30
|
1.6%
2/123
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/64
|
3.2%
2/63
|
6.7%
2/30
|
5.7%
7/123
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER