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

Sponsored by:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001489

Purpose

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.

Condition
Epilepsy Epilepsy, Complex Partial

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Dextrose Vigabatrin

U.S. FDA Resources

Study Type:

Observational

Official Title:

The Effect of Vigabatrin on Cerebral Blood Flow and Glucose Metabolism

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:

20

Study Start Date:

October 1994

Estimated Study Completion Date:

August 2000

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.

Eligibility

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001489

Locations

United States, Maryland
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

More Information

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.

Study ID Numbers:

950008, 95-N-0008

First Received:

November 3, 1999

Last Updated:

March 3, 2008

ClinicalTrials.gov Identifier:

NCT00001489

Health Authority:

United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Cerebral Metabolism
Complex Partial Seizures
Epilepsy

Study placed in the following topic categories:

Epilepsies, Partial
Epilepsy, Complex Partial
Vigabatrin
Epilepsy

Seizures
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases

GABA Agents
Enzyme Inhibitors
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 09, 2009