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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of California, Los Angeles |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004776 |
OBJECTIVES:
I. Evaluate the safety and efficacy of oral topiramate in patients with Lennox-Gastaut syndrome.
Condition | Intervention | Phase |
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Lennox-Gastaut Syndrome |
Drug: topiramate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study |
Estimated Enrollment: | 10 |
Study Start Date: | November 1993 |
PROTOCOL OUTLINE: This is a randomized, double-blind study. Following a 28-day baseline period, patients are randomly assigned to oral topiramate or placebo. The dose of study medication is titrated over the first 3 weeks; the maintenance dose is administered for the next 5 weeks.
Extended topiramate treatment is available to all patients after randomized therapy.
Ages Eligible for Study: | 4 Years to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Lennox-Gastaut syndrome Slow spike and wave pattern on electroencephalogram At least 60 seizures with atypical absence and drop attacks within 1 month Seizure types allowed in addition to those above: Tonic Tonic-clonic Myoclonic Minor motor Absence of progressive lesion confirmed by computerized tomography or magnetic resonance imaging No change documented by physical exam subsequent to imaging No generalized status epilepticus within 3 months while complying with drug therapy No seizures resulting from progressive disease, e.g.: Active infection Neoplasm Metabolic disorder No anoxic episode requiring resuscitation within 1 year --Prior/Concurrent Therapy--
1 or 2 concurrent maintenance antiepileptics required At least 6 months since corticotropin At least 60 days since acetazolamide or zonisamide At least 60 days since investigational drug or device No ketogenic diet --Patient Characteristics-- Hematopoietic: No hematological abnormality within 2 years Hepatic: No hepatic disease within 2 years Renal: No nephrolithiasis No other renal disease within 2 years Cardiovascular: No clinically significant electrocardiographic abnormality No cardiovascular disease within 2 years Pulmonary: No respiratory disease within 2 years Other: Weight at least 25 lb (11.5 kg) No medical disease within 2 years, e.g.: Rheumatic fever Gastrointestinal abnormality Malignancy No psychiatric or mood disorder inconsistent with Lennox-Gastaut within 6 months requiring any of the following: Electroconvulsive therapy Antidepressants Anxiolytics Antipsychotics Lithium carbonate No history of alcohol or drug abuse No history of poor compliance on past antiepileptic therapy Able to take medication and maintain seizure calendar (assistance allowed) Adequate parental supervision 1 parent/guardian with adequate English fluency if English not patient's primary language The following required of fertile women: Negative serum-beta pregnancy test immediately prior to entry Normal menstrual flow for 3 months prior to entry Medically acceptable form of contraception during study
Study ID Numbers: | 199/11821, UCLA-567 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004776 |
Health Authority: | United States: Federal Government |
Lennox-Gastaut syndrome epilepsy neurologic and psychiatric disorders rare disease seizures |
Hemiplegia Seizures Rare Diseases Central Nervous System Diseases Brain Diseases Paralysis Signs and Symptoms |
Epilepsy Mental Disorders Epileptic encephalopathy, Lennox-Gastaut type Neurologic Manifestations Cutis verticis gyrata Topiramate |
Anti-Obesity Agents Pathologic Processes Disease Therapeutic Uses Syndrome Physiological Effects of Drugs |
Nervous System Diseases Protective Agents Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |