Trial Outcomes & Findings for A Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic Neuralgia (NCT NCT01129531)
NCT ID: NCT01129531
Last Updated: 2013-11-15
Results Overview
Participants rated the severity of their daily pain in the previous 7 days using a 10 point scale where 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
294 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2013-11-15
Participant Flow
There were two Treatment Cycles in this study 12 weeks apart. In Treatment Cycle 1 participants were randomized to AGN-214868 3.25 μg, AGN-214868 16.25 μg or Placebo. In Treatment Cycle 2 participants were re-randomized to AGN-214868 3.25 μg, AGN-214868 16.25 μg or Placebo.
Participant milestones
| Measure |
AGN-214868 3.25 μg
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
|
AGN-214868 16.25 μg
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
|
Placebo
Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
|
|---|---|---|---|
|
Treatment Cycle 1
STARTED
|
84
|
84
|
126
|
|
Treatment Cycle 1
COMPLETED
|
80
|
78
|
110
|
|
Treatment Cycle 1
NOT COMPLETED
|
4
|
6
|
16
|
|
Treatment Cycle 2
STARTED
|
94
|
95
|
79
|
|
Treatment Cycle 2
COMPLETED
|
88
|
92
|
74
|
|
Treatment Cycle 2
NOT COMPLETED
|
6
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic Neuralgia
Baseline characteristics by cohort
| Measure |
AGN-214868 3.25 μg
n=84 Participants
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
|
AGN-214868 16.25 μg
n=84 Participants
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
|
Placebo
n=126 Participants
Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
|
Total
n=294 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18 to < 40 Years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Customized
40 to < 65 Years
|
18 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Age, Customized
65 to < 75 Years
|
42 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Age, Customized
≥ 75 Years
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
164 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.
Participants rated the severity of their daily pain in the previous 7 days using a 10 point scale where 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
AGN-214868 3.25 μg
n=84 Participants
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
|
AGN-214868 16.25 μg
n=82 Participants
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
|
Placebo
n=124 Participants
Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
|
|---|---|---|---|
|
Change From Baseline in the Average Pain Intensity Score at Week 12
Baseline
|
6.13 Score on a scale
Standard Deviation 1.248
|
6.04 Score on a scale
Standard Deviation 1.324
|
6.05 Score on a scale
Standard Deviation 1.334
|
|
Change From Baseline in the Average Pain Intensity Score at Week 12
Change from Baseline at Week 12
|
-1.42 Score on a scale
Standard Deviation 1.876
|
-1.35 Score on a scale
Standard Deviation 1.996
|
-1.27 Score on a scale
Standard Deviation 2.036
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.
A tracing of the area of spontaneous pain was made and sent to an independent central reading center for measurement. The area of spontaneous pain was measured in centimeters squared (cm\^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
AGN-214868 3.25 μg
n=84 Participants
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
|
AGN-214868 16.25 μg
n=82 Participants
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
|
Placebo
n=124 Participants
Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
|
|---|---|---|---|
|
Change From Baseline in Area of Spontaneous Pain
Baseline
|
87.44 cm^2
Standard Deviation 51.312
|
118.17 cm^2
Standard Deviation 74.858
|
98.27 cm^2
Standard Deviation 62.866
|
|
Change From Baseline in Area of Spontaneous Pain
Change from Baseline at Week 12 (N=81, 79, 117)
|
-4.83 cm^2
Standard Deviation 62.374
|
-17.18 cm^2
Standard Deviation 62.694
|
-6.13 cm^2
Standard Deviation 68.990
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.
A tracing of the area of allodynia (pain to touch) was made and sent to an independent central reading center for measurement. The area of allodynia was measured in centimeters squared (cm\^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
AGN-214868 3.25 μg
n=84 Participants
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
|
AGN-214868 16.25 μg
n=82 Participants
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
|
Placebo
n=124 Participants
Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
|
|---|---|---|---|
|
Change From Baseline in Area of Allodynia
Baseline
|
184.28 cm^2
Standard Deviation 145.259
|
195.11 cm^2
Standard Deviation 149.355
|
174.17 cm^2
Standard Deviation 134.132
|
|
Change From Baseline in Area of Allodynia
Change from Baseline at Week 12 (N=81, 79, 117)
|
-32.40 cm^2
Standard Deviation 89.849
|
-43.56 cm^2
Standard Deviation 107.183
|
-15.27 cm^2
Standard Deviation 116.338
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.
Participants were asked to rate the unpleasantness (pain to touch) after 3 brush strokes in the area of allodynia on a 100 point scale where 0=no pain to 100=worst pain imaginable. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
AGN-214868 3.25 μg
n=84 Participants
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
|
AGN-214868 16.25 μg
n=82 Participants
AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
|
Placebo
n=124 Participants
Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
|
|---|---|---|---|
|
Change From Baseline in Evoked Pain Score in the Area of Allodynia
Baseline
|
60.8 Score on a scale
Standard Deviation 22.39
|
58.4 Score on a scale
Standard Deviation 24.04
|
60.0 Score on a scale
Standard Deviation 22.39
|
|
Change From Baseline in Evoked Pain Score in the Area of Allodynia
Change from Baseline at Week 12 (N=82, 80, 118)
|
-11.7 Score on a scale
Standard Deviation 25.36
|
-7.9 Score on a scale
Standard Deviation 28.61
|
-11.1 Score on a scale
Standard Deviation 27.64
|
Adverse Events
AGN-214868 3.25 μg_Cycle 1
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
AGN-214868 16.25 μg_Cycle 1
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo_Cycle 1
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
AGN-214868 3.25 μg_ Cycle 2
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
AGN-214868 16.25 μg_ Cycle 2
Serious events: 5 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo_Cycle 2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AGN-214868 3.25 μg_Cycle 1
n=84 participants at risk
One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg.
|
AGN-214868 16.25 μg_Cycle 1
n=83 participants at risk
One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg.
|
Placebo_Cycle 1
n=125 participants at risk
One treatment of Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain.
|
AGN-214868 3.25 μg_ Cycle 2
n=94 participants at risk
One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg.
|
AGN-214868 16.25 μg_ Cycle 2
n=95 participants at risk
One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg.
|
Placebo_Cycle 2
n=79 participants at risk
One treatment of Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain.
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.3%
1/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.1%
2/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.1%
1/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.1%
1/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Sepsis
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.1%
1/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.1%
1/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.3%
1/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.1%
1/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.1%
1/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.1%
1/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.1%
1/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Cardiac disorders
Cardiac failure chronic
|
1.2%
1/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
General disorders
Chest pain
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.2%
1/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.2%
1/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
1/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.80%
1/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.1%
1/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.1%
1/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.3%
1/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.1%
1/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Psychiatric disorders
Depression
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.3%
1/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.1%
1/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.1%
1/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
Other adverse events
| Measure |
AGN-214868 3.25 μg_Cycle 1
n=84 participants at risk
One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg.
|
AGN-214868 16.25 μg_Cycle 1
n=83 participants at risk
One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg.
|
Placebo_Cycle 1
n=125 participants at risk
One treatment of Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain.
|
AGN-214868 3.25 μg_ Cycle 2
n=94 participants at risk
One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg.
|
AGN-214868 16.25 μg_ Cycle 2
n=95 participants at risk
One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg.
|
Placebo_Cycle 2
n=79 participants at risk
One treatment of Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/84
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.2%
1/83
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.6%
2/125
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
6.4%
6/94
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.1%
1/95
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
3.8%
3/79
The safety population (all participants who received at least one dose of study medication) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER