At a glance
ClinicalIndex Comparison Record- ✓Age ≥13 years
- ✓Confident diagnosis of epilepsy with PGTC seizures for >24 weeks prior to Baseline Phase
- ✓EEG evidence of generalized (spike-and-wave) pattern with no focal abnormalities
- ✓At least 1 PGTC seizure in the 8 weeks prior to Baseline Phase
- ✕History of partial seizures or EEG evidence of partial seizures
- ✕Status epilepticus within 24 weeks prior to or during Baseline Phase
- ✕Currently taking ≥3 background AEDs chronically
- ✕Diagnosis of Lennox-Gastaut syndrome
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-Release Adjunctive Therapy in Patients With Primary Generalized Tonic-Clonic Seizures
In Brief
A Phase 3 clinical trial evaluating lamotrigine (LAMICTAL) extended-release and Placebo for Epilepsy, Tonic-Clonic. Completed, enrolled 153 participants across 146 sites in 11 countries.
Detailed 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.
Study Details
Timeline
Interventions
Primary experimental dosage form
Placebo control