Study of Phenobarbital Inhibition of Catamenial Epilepsy

Not Applicable

Withdrawn

• Conditions: Epilepsy
• Interventions: Other: Placebo; Drug: Phenobarbital

• Registration Number: NCT00530413
• Lead Sponsor: University of Toledo Health Science Campus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-09-13
• Study First Submitted QC: 2007-09-13
• Study First Posted: 2007-09-17
• Primary Completion: 2009-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-09
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo group
1	Phenobarbital	Phenobarbital - dose based by weight range

Primary Outcome Measures

Name	Time	Method
Addenbrooke's Cognitive Examination (ACE)	Screening, 3 month and Final Visit
Quality of Life in Epilepsy (QOLIE-10)	Screening, 3 month and Final Visit
Patient Health Questionnaire (PHQ-9)	Screening, 3 month and final visit
Depression Epworth Sleepiness Scale (ESS)	Screening, 3 month and final visit

Secondary Outcome Measures

Name	Time	Method
Determine tolerance of medication using the depression, cognitive and sleepiness screening tools listed above	Screening, 3 months, final visit

Trial Locations

Locations (1)

University of Toledo, Health Science Campus; 🇺🇸 Toledo, Ohio, United States