Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pregabalin add-on therapy · 1 trial · 1 indication
All partial onset seizures experienced during baseline phase were recorded by the participants or their parents/legal guardian, in a daily seizure diary. 28-day seizure rate for all partial onset seizures = (\[number of seizures in the baseline phase\] divided by \[number of days in baseline phase minus {-} number of missing diary days in baseline phase\])\*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).
All partial onset seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all partial onset seizures = (\[number of seizures in the treatment phase\] divided by \[number of days in treatment phase minus {-} number of missing diary days in treatment phase\])\*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| Pregabalin Level 1 (max 150 mg/day) | EXPERIMENTAL | - |
| Pregabalin Level 2 (max 600 mg day) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Pregabalin add-on therapy | DRUG | Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period. |
Inclusion Criteria: * Subjects and/or parent(s)/legally acceptable representative must be considered willing and able to sign consent, and complete daily seizure diaries and monitor seizure frequency. * Male and female epilepsy subjects, 4 to 16 years of age inclusive on the date of the Screening V...