Conditions: Epilepsy, Tonic-Clonic
Keywords: antiepileptic drugs seizures primary generalized tonic-clonic seizures Epilepsy lamotrigine anticonvulsants LAMICTAL
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 153
Healthy volunteers: no

Brief summary:
This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of Primary Generalized Tonic-Clonic (PGTC) seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: lamotrigine (LAMICTAL) extended-release intervention 2: Placebo
Intervention descriptions: intervention 1: Primary experimental dosage form intervention 2: Placebo control

Protocol document: