Effect of Vigabatrin on Brain Blood Flow and Glucose Metabolism - Tabular View

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	March 3, 2008
Start Date ^ICMJE	October 1994
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001489 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Effect of Vigabatrin on Brain Blood Flow and Glucose Metabolism
Official Title ^ICMJE	The Effect of Vigabatrin on Cerebral Blood Flow and Glucose Metabolism
Brief Summary	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.
Detailed 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.
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE
Condition ^ICMJE	Epilepsy Epilepsy, Complex Partial
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *	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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	August 2000
Primary Completion Date
Eligibility Criteria ^ICMJE	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	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001489
Responsible Party
Study ID Numbers ^ICMJE	950008, 95-N-0008
Study Sponsor ^ICMJE	National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	August 1999
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP