NCT00113165CompletedPhase 3
A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects With Partial Seizures
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 244
- Locations
- 148
- Primary Endpoint
- The efficacy of LAMICTAL extended-release therapy will be measured by the percentage change from Baseline in partial seizure frequency during the double-blind treatment phase.
Study Overview
Brief Summary
This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of epilepsy with partial seizures for more than 24 weeks.
- •Must experience at least 8 partial seizures during an 8-week Baseline Phase.
- •Must currently be receiving treatment with a stable regimen of one or two antiepileptic drugs for at least four weeks.
- •Patient or parent/caregiver must be willing and able to maintain a written daily seizure diary.
Exclusion Criteria
- •Previous treatment with lamotrigine.
- •Exhibits any primary generalized seizures.
- •Receiving treatment with felbamate or currently following the ketogenic diet.
- •Pregnant, breastfeeding, or planning to become pregnant.
Outcomes
Primary Outcomes
The efficacy of LAMICTAL extended-release therapy will be measured by the percentage change from Baseline in partial seizure frequency during the double-blind treatment phase.
Time Frame: 24 Weeks
Secondary Outcomes
- Reduction in partial seizure frequency during portions of double-blind phase (=25%,=50%,=75%,100%). Time to 50% reduction in partial seizure frequency. Adverse events. Weight change. Health outcomes questionnaires. Population Pharmacokinetics(24 Weeks)
Investigators
Study Sites (148)
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