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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01888497 | Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers | PHASE3 | COMPLETED | 59 | — | — | Jul 29, 2013 | Dec 14, 2013 | Feb 21, 2021 | 4 | United States |
Driving performance assessment for the participants were measured by simulated driving test using Cognitive Research Corporation Driving Simulator (CRCDS-MiniSim). The assessment was performed after 45 minutes of awakening from approximately 6.5 hours of sleep on testing day (after 7.25 hours of study drug administration). SDLP was used to assess driver's ability to track their lane and was the standard deviation of lane positions through the entire drive.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | - |
| Arm B | EXPERIMENTAL | - |
| Arm C | ACTIVE_COMPARATOR | - |
| Arm D | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Gabapentin | DRUG | 250 mg, oral, prior to bedtime on the night before performance testing |
| Diphenhydramine citrate | DRUG | 76 mg, oral, prior to bedtime on the night before performance testing |
| Triazolam | DRUG | 0.5 mg, oral, prior to bedtime on the night before performance testing |
| Placebo | DRUG | Oral, prior to bedtime on the night before performance testing |
Inclusion Criteria: * Healthy males and females of non-childbearing potential, 25-55 years of age * Valid driver's license Exclusion Criteria: * Psychiatric disorder * Recent history of clinically significant neurological disorder, such as seizures, stroke, multiple sclerosis, or head trauma * Re...