Neuralgia
Conditions
Brief summary
This study will explore the safety and efficacy of AGN201781 in patients with postherpetic neuralgia or post-traumatic peripheral neuralgia
Interventions
DRUGplacebo
placebo 50 mg capsules three-times daily for 2 weeks
DRUGAGN201781
AGN201781 50 mg capsules three-times daily for 2 weeks
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of postherpetic neuralgia or post-traumatic peripheral neuralgia * Moderate or severe pain associated with postherpetic neuralgia or post-traumatic peripheral neuralgia
Exclusion criteria
* Women of child-bearing potential * Any other uncontrolled diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Daily Pain Score at Week 2 | Baseline, Week 2 | Change from baseline in the daily-average-pain score at week 2. This was measured using a 11-point (0 to 10) scale where 0 represented no pain and 10 represented worst pain. Due to the low number of patients completing the treatment period of the study no analyses were performed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Subject Global Impression of Change Score at Week 2 | Baseline, Week 2 | Change from baseline in Subject Global Impression of Change score at week 2. The Subject Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale (1=very much improved to 7=very much worse). Due to low number of patients completing the treatment period of the study no analyses were performed. |
Countries
Australia, Germany
Participant flow
Pre-assignment details
There were 2 Treatment Periods in this Cross-Over Study. Patients randomized to AGN201781 during Period 1 received Placebo during Period 2. Patients randomized to Placebo during Period 1 received AGN201781 during Period 2. Period 3 was an Observational Period only (No treatment provided).
Participants by arm
| Arm | Count |
|---|---|
| AGN201781 Followed by Placebo | 7 |
| Placebo Followed by AGN201781 | 2 |
| Total | 9 |
Baseline characteristics
| Characteristic | AGN201781 Followed by Placebo | Placebo Followed by AGN201781 | Total |
|---|---|---|---|
| Age, Continuous | 60.6 years STANDARD_DEVIATION 11.01 | 49 years STANDARD_DEVIATION 36.77 | 54.8 years STANDARD_DEVIATION 23.89 |
| Sex: Female, Male Female | 5 Participants | 0 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 7 | 1 / 2 |
| serious Total, serious adverse events | 0 / 7 | 0 / 2 |
Outcome results
Primary
Change From Baseline in Daily Pain Score at Week 2
Change from baseline in the daily-average-pain score at week 2. This was measured using a 11-point (0 to 10) scale where 0 represented no pain and 10 represented worst pain. Due to the low number of patients completing the treatment period of the study no analyses were performed
Time frame: Baseline, Week 2
Population: Due to low number of patients completing the treatment period of the study no analyses were performed
Secondary
Change From Baseline in Subject Global Impression of Change Score at Week 2
Change from baseline in Subject Global Impression of Change score at week 2. The Subject Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale (1=very much improved to 7=very much worse). Due to low number of patients completing the treatment period of the study no analyses were performed.
Time frame: Baseline, Week 2
Population: Due to low number of patients completing the treatment period of the study no analyses were performed.