Study of Phenobarbital Inhibition of Catamenial Epilepsy

Study Overview
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Brief Summary
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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.

Official Title
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Study of Phenobarbital Inhibition of Catamenial Epilepsy

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Phenobarbital
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Phenobarbital - dose based by weight range | Drug: Phenobarbital<br>* Phenobarbital will be given based on weight range<br>|
| Placebo Comparator: 2<br>Placebo group | Other: Placebo<br>* Placebo group<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine tolerance of medication using the depression, cognitive and sleepiness screening tools listed above |  | Screening, 3 months, final visit |