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

• 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
• 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

Contacts

• Name: W. Donald Shields
• 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

Secondary ID(s)

UCLA-567

199/11821

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of California, Los Angeles