A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC AND ADULT SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES - PROTOCOL A0081105
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC AND ADULT SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES - PROTOCOL A0081105
The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.
Inclusion Criteria:
Exclusion Criteria:
Prijedor, Republika Srpska 79101, Bosnia and Herzegovina
Chongqing, Chongqing Municipality 400016, China
El Chouf, Lebanon
Pgt. Roshchino, Leningradskaya Oblast' 188820, Russia
Chelyabinsk, 454048, Russia
Istanbul, UST Kaynarca/pendik 34899, Turkey (Türkiye)
Eskişehir, 26480, Turkey (Türkiye)
S. Oleksandrivka, Komintern. R-N, Odeska OBL. 67513, Ukraine
Kharkiv, 61068, Ukraine
Zaporizhzhya, 69068, Ukraine