Back to resultsEffect of Vigabatrin on Brain Blood Flow and Glucose Metabolism
Primary Purpose
Epilepsy, Epilepsy, Complex Partial
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Epilepsy focused on measuring Cerebral Metabolism, Complex Partial Seizures, Epilepsy
Eligibility 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.
Sites / Locations
- National Institute of Neurological Disorders and Stroke (NINDS)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001489
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT00001489
Brief Title
Effect of Vigabatrin on Brain Blood Flow and Glucose Metabolism
Official Title
The Effect of Vigabatrin on Cerebral Blood Flow and Glucose Metabolism
Study Type
Observational
2. Study Status
Record Verification Date
August 1999
Overall Recruitment Status
Completed
Study Start Date
October 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Epilepsy, Complex Partial
Keywords
Cerebral Metabolism, Complex Partial Seizures, Epilepsy
7. Study Design
Enrollment
20 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
2474312
Citation
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(Suppl 1):79S-85S. doi: 10.1111/j.1365-2125.1989.tb03466.x.
Results Reference
background
PubMed Identifier
3808298
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. doi: 10.1212/wnl.37.2.184.
Results Reference
background
Learn more about this trial
Effect of Vigabatrin on Brain Blood Flow and Glucose Metabolism
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