Study of Phenobarbital Inhibition of Catamenial Epilepsy
NCT ID: NCT00530413
Last Updated: 2014-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2007-03-31
Brief Summary
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We propose that since the catamenial seizures are associated with the reduction in levels of GABA-enhancing allopregnanolone, short-term replacement with the GABAR-enhancing agent Phenobarbital will reduce the incidence of catamenial seizures.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Phenobarbital - dose based by weight range
Phenobarbital
Phenobarbital will be given based on weight range
2
Placebo group
Placebo
Placebo group
Interventions
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Phenobarbital
Phenobarbital will be given based on weight range
Placebo
Placebo group
Eligibility Criteria
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Inclusion Criteria
* Regular menstrual cycles
* At least 2 seizures per month
* Must be on at least one form of birth control other than abstinence
* Must be on a stable anticonvulsant regimen of at least one and not exceeding three anticonvulsants, and not be using any perimenstrual seizure medications of hormone preparations
* If taking benzodiazepines for therapeutic purposes, must be on a stable regular dose
* Must be willing to take at least 400mcg of folic acid a day while in the study
* Must be able to detect, count or record seizures
Exclusion Criteria
* Can not have used hormonal birth control methods for at least 3 months prior to enrollment
* Can not have an allergy to Phenobarbital
* Can not have a history of non-epileptic seizures
* Can not have a know liver dysfunction or history of chronic hepatitis
* Can not have a history of neurological disorder or history of status epilepticus in the preceding year
* Can not ahve a physical or psychiatric condition which in the PIs opinion could compromise her ability to participate
18 Years
45 Years
FEMALE
No
Sponsors
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University of Toledo Health Science Campus
OTHER
Responsible Party
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Principal Investigators
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Lazar J Greenfield, Jr, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toledo Health Science Campus
Locations
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University of Toledo, Health Science Campus
Toledo, Ohio, United States
Countries
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Other Identifiers
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xUTHSC-07
Identifier Type: -
Identifier Source: org_study_id