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Effect of Vigabatrin on Brain Blood Flow and Glucose Metabolism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001489
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  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

Study Type: Observational
Official Title: The Effect of Vigabatrin on Cerebral Blood Flow and Glucose Metabolism

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00001489     History of Changes
Other Study ID Numbers: 950008
95-N-0008
First Submitted: November 3, 1999
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: August 1999

Keywords provided by National Institutes of Health Clinical Center (CC):
Cerebral Metabolism
Complex Partial Seizures
Epilepsy

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Complex Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial
Vigabatrin
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs