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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00104416 |
This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of PGTC 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.
Condition | Intervention | Phase |
---|---|---|
Seizures, Tonic-Clonic Epilepsy |
Drug: lamotrigine (LAMICTAL) extended-release |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-Blind, Randomized, Parallel-Group Evaluation of LAMICTAL Extended-Release Adjunctive Therapy in Subjects With Primary Generalized Tonic-Clonic Seizures |
Estimated Enrollment: | 216 |
Study Start Date: | December 2004 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Has at least 3 PGTC seizures occurring anytime during an 8-week (i.e., 56 days) prospective Baseline Phase.
NOTE: With authorization from GSK, a maximum of four weeks (i.e., 28 days) of historical seizure data may replace up to four weeks (i.e., 28 days) of the prospective Baseline Phase for subjects providing reliable documentation of the following (see Section 14.2, Appendix 2: "Guidelines for Using a Historical Baseline Phase"):
Is currently treated with a stable regimen of one or two AED(s) for at least four weeks prior to starting the Baseline Phase (historical or prospective).
NOTE: Subjects with surgically implanted vagal nerve stimulators (VNS) will be allowed to enter the study provided that all of the following conditions are met ("Vagal Nerve Stimulators":
If female, and of childbearing potential, must be using an acceptable form of birth control, to include one of the following:
Consistent and correct use of one of the following methods of birth control:
Exclusion Criteria:
NOTE: Use of benzodiazepines is allowed as specified in Section 8.1.2, "Use of Benzodiazepines".
Exclusion criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | LAM100036 |
Study First Received: | February 28, 2005 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00104416 |
Health Authority: | United States: Food and Drug Administration; Russia: Ministry of Health and Social Development of the Russian Federation |
Epilepsy primary generalized tonic-clonic seizures seizures lamotrigine |
anticonvulsants antiepileptic drugs LAMICTAL |
Calcium, Dietary Signs and Symptoms Epilepsy Seizures |
Lamotrigine Neurologic Manifestations 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 |