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| Sponsored by: |
GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00043901 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Drug: lamotrigine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study |
| Official Title: | A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Evaluation of Lamotrigine Adjunctive Therapy in Subjects Wtih Primary Generalized Tonic-Clonic Seizures |
| Estimated Enrollment: | 104 |
| Study Start Date: | December 2000 |
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Contacts and Locations
Show 89 Study Locations| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | LAM40097 |
| Study First Received: | August 14, 2002 |
| Last Updated: | June 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00043901 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |
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Lamotrigine epilepsy primary generalized tonic-clonic PGTC seizures |
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Calcium, Dietary Signs and Symptoms Epilepsy Seizures Lamotrigine Calcium Channel Blockers |
Neurologic Manifestations Central Nervous System Diseases Cardiovascular Agents Brain Diseases Anticonvulsants |
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Molecular Mechanisms of Pharmacological Action Seizures Nervous System Diseases Central Nervous System Diseases Calcium Channel Blockers Cardiovascular Agents Brain Diseases Pharmacologic Actions |
Membrane Transport Modulators Signs and Symptoms Epilepsy Therapeutic Uses Lamotrigine Neurologic Manifestations Central Nervous System Agents Anticonvulsants |