Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication NEURONTIN ® is indicated for: • Management of postherpetic neuralgia in adults • Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy NEURONTIN is indicated for: • Postherpetic neuralgia in adults ( 1 ) • Adjunctive therapy in the treatment of partial onset seizures, with and without secondary…
Gabapentin · 9 trials · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| gabapentin | EXPERIMENTAL | - |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | PLACEBO_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Gabapentin 250 mg | EXPERIMENTAL | - |
| Gabapentin 500 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| gabapentin | DRUG | Orally administered gabapentin |
| Placebo | DRUG | Matched placebo oral capsule 30 minutes prior to bedtime |
Inclusion Criteria: * Completion of study A9451162 (NCT00603473) Exclusion Criteria: * Seizures related to drugs or acute medical illness * History of any serious medical or psychiatric disorder