Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gabapentin · 12 trials · 3 indications
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.
Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. Severe AEs: those which interferes significantly with participant's usual function. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.
The Response Ratio calculated by the following equation was assessed as the primary endpoint: R Ratio = (T-B) / (T+B) where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period.
Area under the cold pain test Visual Analog Scale (VAS) time curve (AUCcpt 0 to 120 seconds \[sec\]) averaged over the 120 sec for each time point assessed. Participant adjusted 100 millimeter (mm) electronic VAS with range of "no pain" (0) to "maximum pain" (100) at the anchor endpoints of the scale and "moderate pain" at the midpoint. Pain reported while non-dominant hand was placed in thermostatically controlled water bath at 2±1°C for a maximum of 120 sec.
Interpolated average pain (0 to 8 hours): area under the curve (AUC) of average pain (0 to 120 seconds) recorded at each of the time points taken over 8 hour time period divided by 8.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | - |
| Arm B | EXPERIMENTAL | - |
| Arm C | ACTIVE_COMPARATOR | - |
| Arm D | PLACEBO_COMPARATOR | - |
| gabapentin | EXPERIMENTAL | - |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | PLACEBO_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Gabapentin 250 mg | EXPERIMENTAL | - |
| Gabapentin 500 mg | EXPERIMENTAL | - |
| Period I: Tablet(400 mg single dose) | EXPERIMENTAL | Period I: Tablet in fasting state, Period II: Liquid formulation in fasting state, Period III: Liquid formulation in fed state |
| Period I: Liquid formulation(400 mg single dose) | EXPERIMENTAL | Period I: Liquid formulation in fasting state, Period II: Tablet in fasting state, Period III: Liquid formulation in fed state |
| Gabapentin 1200mg | ACTIVE_COMPARATOR | - |
| Diphenhydramine 50 mg | ACTIVE_COMPARATOR | - |
| Morphine 10 mg | ACTIVE_COMPARATOR | - |
| Placebo formulations | 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 |
| Diphenhydramine | DRUG | Tablet, single 50mg dose |
| Morphine | DRUG | IV, single 10mg dose |
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...