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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00043875 |
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.
Condition | Intervention | Phase |
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Epilepsy |
Drug: lamotrigine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled, Add-on Clinical Trial of the Safety, Pharmacokinetics and Efficacy of LAMICTAL in Pediatric Age Subjects (1-24 Months) |
Enrollment: | 250 |
Study Start Date: | May 2000 |
Ages Eligible for Study: | 1 Month to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | LAM20006 |
Study First Received: | August 14, 2002 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00043875 |
Health Authority: | United States: Food and Drug Administration; Lithuania: State Medicine Control Agency - Ministry of Health |
epilepsy partial seizures pediatric |
Calcium, Dietary Epilepsy Seizures |
Lamotrigine Central Nervous System Diseases Brain Diseases |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Therapeutic Uses Nervous System Diseases Calcium Channel Blockers |
Cardiovascular Agents Central Nervous System Agents Anticonvulsants Pharmacologic Actions |