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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome
This study has been completed.
First Received: February 24, 2000   Last Updated: June 23, 2005   History of Changes
Sponsors and Collaborators: National Center for Research Resources (NCRR)
University of California, Los Angeles
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00004776
  Purpose

OBJECTIVES:

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


Condition Intervention Phase
Lennox-Gastaut Syndrome
Drug: topiramate
Phase III

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy
MedlinePlus related topics: Epilepsy
Drug Information available for: Topiramate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 10
Study Start Date: November 1993
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.

  Eligibility

Ages Eligible for Study:   4 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004776

Sponsors and Collaborators
University of California, Los Angeles
Investigators
Study Chair: W. Donald Shields University of California, Los Angeles
  More Information

No publications provided

Study ID Numbers: 199/11821, UCLA-567
Study First Received: February 24, 2000
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00004776     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
Lennox-Gastaut syndrome
epilepsy
neurologic and psychiatric disorders
rare disease
seizures

Study placed in the following topic categories:
Hemiplegia
Epileptic Encephalopathy, Lennox-Gastaut Type
Seizures
Rare Diseases
Central Nervous System Diseases
Cutis Verticis Gyrata
Brain Diseases
Neuroprotective Agents
Paralysis
Anti-Obesity Agents
Signs and Symptoms
Epilepsy
Mental Disorders
Neurologic Manifestations
Topiramate
Anticonvulsants

Additional relevant MeSH terms:
Hemiplegia
Disease
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Paralysis
Anti-Obesity Agents
Signs and Symptoms
Pathologic Processes
Epilepsy
Therapeutic Uses
Syndrome
Neurologic Manifestations
Topiramate
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009