NCT00001489

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 1994

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1994

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2000

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

August 1, 1999

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

EpilepsyEpilepsy, Complex Partial

Keywords

Cerebral MetabolismComplex Partial SeizuresEpilepsy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related 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(Suppl 1):79S-85S. doi: 10.1111/j.1365-2125.1989.tb03466.x.

    PMID: 2474312BACKGROUND

  • 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.

    PMID: 3808298BACKGROUND

MeSH Terms

Conditions

EpilepsyEpilepsy, Complex PartialSeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpilepsies, PartialNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

October 1, 1994

Study Completion

August 1, 2000

Last Updated

March 4, 2008

Record last verified: 1999-08

Locations

US(1)