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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00044278 |
This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.
Condition | Intervention | Phase |
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Epilepsy |
Drug: lamotrigine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-Naive Subjects (1-24 Months of Age) |
Enrollment: | 225 |
Study Start Date: | September 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: | LAM20007 |
Study First Received: | August 23, 2002 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00044278 |
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 |