Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug
Phase 4
Completed
- Conditions
- Epilepsy, Tonic-Clonic
- Registration Number
- NCT00043901
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of an investigational new drug for supplemental therapy in subjects with primary generalized tonic-clonic (PGTC) seizures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 141
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method % change from Baseline in average monthly PGTC seizure frequency
- Secondary Outcome Measures
Name Time Method Proportion of subjects with >/= 25%, 50%, 75% or 100% reduction in PGTC seizures %change from Baseline in average monthly seizure frequency.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie lamotrigine's efficacy in primary generalized tonic-clonic seizures?
How does lamotrigine adjunctive therapy compare to standard-of-care treatments for PGTC seizures in Phase 4 trials?
Which biomarkers correlate with lamotrigine response in epilepsy patients with generalized tonic-clonic seizures?
What adverse events are associated with lamotrigine in long-term adjunctive therapy for PGTC seizures?
Are there combination therapies or competitor drugs to lamotrigine for managing refractory generalized tonic-clonic epilepsy?
Trial Locations
- Locations (1)
GSK Investigational Site
🇵🇪San Isidro, Lima, Peru
GSK Investigational Site🇵🇪San Isidro, Lima, Peru