Study of Phenobarbital Inhibition of Catamenial Epilepsy

University of Toledo Health Science Campus

Status

Withdrawn

Conditions

Epilepsy

Treatments

Drug: Phenobarbital

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00530413

xUTHSC-07

Details and patient eligibility

About

The purpose of this study is to test the effectiveness of low-dose Phenobarbital on the treatment of catamenial epilepsy.

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.

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult female patients seeking medical attention for seizures
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 be pregnant or trying to become pregnant
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