Pediatric Epilepsy Trial in Subjects 1-24 Months
Phase 2
Completed
- Conditions
- Epilepsy
- Registration Number
- NCT00043875
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to the current therapy of pediatric patients age 1-24 months old with partial seizures. The medication used in this study has been approved by FDA for the adjunctive treatment of partial seizures in patients 2 years and older.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 177
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The efficacy of LAMICTAL add-on therapy will be measured by the proportion of subjects who meet escape criteria during the Double-Blind Phase. 36 Months
- Secondary Outcome Measures
Name Time Method Time to escape patterns in Double-Blind phase. Reduction in partial seizure frequency at end of Open-Label Phase. Investigators' global evaluation of subjects' status at end of Open-Label and Double-Blind Phases; Standard pharmacokinetics; Adverse Events 36 Months
Trial Locations
- Locations (1)
GSK Investigational Site
🇹🇷Ankara, Turkey
GSK Investigational Site🇹🇷Ankara, Turkey