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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome Clinical research trials and Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome. Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome clinical trial. Subjects often receive the most expert healthcare possible for their Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome  Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome
For Condition: Lennox-Gastaut Syndrome
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , University of California, Los Angeles
Synopsis: OBJECTIVES: I. Evaluate the safety and efficacy of oral topiramate in patients with Lennox-Gastaut syndrome.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Minimum Age/Maximum Age: 4 Years/30 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 10
Location and Contact Information:
Overall Study Official:
W.Shields, Study Chair, University of California, Los Angeles
Additional Information:
Study ID Numbers: 199/11821; UCLA-567
Study Start Date: November 1993
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004776
Other Lennox-Gastaut Syndrome Studies:
1. Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome
2. Ketogenic Diet for Child Epilepsy and Seizure Control
Related Studies:
Other Lennox-Gastaut Syndrome Clinical Trials
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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome
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