Study of Phenobarbital Inhibition of Catamenial Epilepsy

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Toledo Health Science Campus
• Treatments: Phenobarbital

Criteria

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