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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004776
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
University of California, Los Angeles
Information provided by:
Office of Rare Diseases (ORD)

Brief Summary:


I. Evaluate the safety and efficacy of oral topiramate in patients with Lennox-Gastaut syndrome.

Condition or disease Intervention/treatment Phase
Lennox-Gastaut Syndrome Drug: topiramate Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : November 1993

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004776

Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of California, Los Angeles
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Study Chair: W. Donald Shields University of California, Los Angeles
Layout table for additonal information Identifier: NCT00004776    
Other Study ID Numbers: 199/11821
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2001
Keywords provided by Office of Rare Diseases (ORD):
Lennox-Gastaut syndrome
neurologic and psychiatric disorders
rare disease
Additional relevant MeSH terms:
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Lennox Gastaut Syndrome
Pathologic Processes
Epileptic Syndromes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Hypoglycemic Agents
Physiological Effects of Drugs