Effect of Vigabatrin on Brain Blood Flow and Glucose Metabolism

Epilepsy Clinical Trial

Official title:

The Effect of Vigabatrin on Cerebral Blood Flow and Glucose Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001489
• Other study ID #: 950008
• Secondary ID: 95-N-0008
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: October 1994
• Est. completion date: August 2000

Study information

• Verified date: August 1999
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Complex Partial

Locations

Country	Name	City	State
United States	National Institute of Neurological Disorders and Stroke (NINDS)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation