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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.
Using a Historical Baseline Phase"):
compliance with background AEDs.
All subjects permitted to use historical seizure data must complete a minimum of four weeks (i.e., 28 days) of the prospective Baseline Phase. The historical Baseline Phase and the prospective Baseline Phase must equal 56 consecutive days.
- 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).
VNS is counted as a "concurrent AED." - Is able and willing to maintain an accurate and complete daily written seizure diary, or has a parent/caregiver who is able and willing to maintain an accurate and complete daily written seizure diary for the entire duration of the study.
Consistent and correct use of one of the following methods of birth control:
·Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject
·Implants of levonorgestrel
·Injectable progestogen
·Oral contraceptive (either combined, with at least 50mg estrogen for women on EIAEDs, or progestogen only)
·Any intrauterine device (IUD) with a documented failure rate of less than 1% per year
·Double barrier method consisting of spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm).
Exclusion Criteria:
- Has a history of partial seizures or interictal expression of partial seizures as evidenced by EEG NOTE: EEG may be historical or prospective in accordance with Section 14.1.
- Has had status epilepticus within the 24 weeks prior to, or during, the Baseline Phase.
- Is taking three or more background AEDs chronically.
- Has Lennox-Gastaut syndrome.
- Is currently using or has previously used lamotrigine.
- Is currently taking felbamate.
- Is abusing alcohol and/or other substance(s).
- Has taken an investigational drug within the previous 30 days or plans to take an investigational drug anytime during the study.
- Is receiving chronic treatment with any medication that could influence seizure control.
NOTE: Use of benzodiazepines is allowed as specified in Section 8.1.2, "Use of Benzodiazepines".
- Is currently following the ketogenic diet.
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: | February 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00104416 History of Changes |
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 Calcium Channel Blockers |
Neurologic Manifestations Central Nervous System Diseases Cardiovascular Agents Brain Diseases Anticonvulsants |
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 |