Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01485185 | Gabapentin and Donepezil Combination on Experimental Human Pain Models | PHASE1 | COMPLETED | 48 | — | — | Oct 11, 2011 | Jul 3, 2012 | Jun 12, 2017 | 1 | United Kingdom |
Change in Area between treatment arms (compared to baseline), measured during the electrical hyperalgesia model using 26 Milli Neuton(mN) von Frey filament
Change in Area between treatment arms (compared to baseline), measured during the electrical hyperalgesia model using a cotton bud
| Arm | Type | Description |
|---|---|---|
| Gabapentin lower dose alone | EXPERIMENTAL | low dose |
| Gabapentin higher dose alone | ACTIVE_COMPARATOR | higher dose |
| Gabapentin in combination with donepezil | EXPERIMENTAL | Gabapentin lower dose and donepezil |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Gabapentin lower dose | DRUG | Repeat, oral dose |
| Donepezil | DRUG | Repeat, oral dose |
| Placebo (Dop) | OTHER | Placebo to donepezil, Repeat, oral dose |
| Placebo (Gaba) | OTHER | Placebo to gabapentin, Repeat, oral dose |
| Gabapentin higher dose | DRUG | Repeat, oral dose |
Inclusion Criteria: 1. Male between 18 and 55 years of age inclusive, at the time of signing the informed consent. 2. Body weight ≥ 50 Kilogram (kg) and BMI within the range 18.5-29.9 Killogram per square meter (kg/m2) (inclusive). 3. Healthy as determined by a responsible and experienced physician...