Oral Topiramate for Lennox-Gastaut Syndrome Treatment
topiramate
Epileptic Syndromes+13
+ Brain Diseases
+ Central Nervous System Diseases
Treatment Study
Summary
Study start date: November 1, 1993
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 4 to 30 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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