This study is designed to test the effects of vigabatrin (gamma-vinyl-GABA) an experimental drug used for the treatment of epilepsy. The study will use positron emission tomography (PET scan) to detect areas of the brain receiving increased blood flow and using increased amounts of glucose. Increases in blood flow and glucose use are good indicators of brain activity. Researchers are interested...
Date First Received: November 3, 1999
Last Updated: March 3, 2008
Verified by: National Institutes of Health Clinical Center (CC), August 1999
Clinical Trial Phase: N/A | Start Date: October 1994
Overall Status: Completed
Estimated Enrollment: 20
Brief Summary
Official Title: “The Effect of Vigabatrin on Cerebral Blood Flow and Glucose Metabolism”
Condition Keyword(s):
This study is designed to test the effects of vigabatrin (gamma-vinyl-GABA) an experimental drug used for the treatment of epilepsy. The study will use positron emission tomography (PET scan) to detect areas of the brain receiving increased blood flow and using increased amounts of glucose. Increases in blood flow and glucose use are good indicators of brain activity.
Researchers are interested in determining the effects of Vigabatrin on brain blood flow and glucose use.
Study Type: Observational
Study Design: N/A
Detailed Clinical Trial Description
This double-blind placebo-controlled parallel design protocol will investigate the effects of gamma-vinyl-GABA (vigabatrin--GVG) an experimental antiepileptic drug, on cerebral glucose metabolism (LCMRglc), blood flow (CBF), and seizure frequency, in patients with uncontrolled complex partial (CPS) and secondary generalized seizures (GTCS). Positron Emission Tomography (PET) will be used to measure CBF and LCMRglc.
Criteria for Participation in this Clinical Trial
- Localization-related epilepsy.
- Uncontrolled seizures.
- Ability to tolerate tegretol monotherapy.
- No systemic illness requiring drug therapy.
- No illness that might be made worse by vigabatrin.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Related Publications
References
Ben-Menachem E, Persson LI, Schechter PJ, Haegele KD, Huebert N, Hardenberg J, Dahlgren L, Mumford JP. The effect of different vigabatrin treatment regimens on CSF biochemistry and seizure control in epileptic patients. Br J Clin Pharmacol. 1989;27 Suppl 1:79S-85S.
Browne TR, Mattson RH, Penry JK, Smith DB, Treiman DM, Wilder BJ, Ben-Menachem E, Napoliello MJ, Sherry KM, Szabo GK. Vigabatrin for refractory complex partial seizures: multicenter single-blind study with long-term follow-up. Neurology. 1987 Feb;37(2):184-9.
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00001489
Study ID Number: 950008
ClinicalTrials.gov Identifier: NCT00001489
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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