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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00004776
Date of registration: 24/02/2000
Prospective Registration: No
Primary sponsor: National Center for Research Resources (NCRR)
Public title: Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome
Scientific title:
Date of first enrolment: November 1993
Target sample size: 10
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00004776
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Contacts
Name:     W. Donald Shields
Address: 
Telephone:
Email:
Affiliation:  University of California, Los Angeles
Key inclusion & exclusion 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



Age minimum: 4 Years
Age maximum: 30 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Lennox-Gastaut Syndrome
Intervention(s)
Drug: topiramate
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
199/11821
UCLA-567
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University of California, Los Angeles
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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