Epilepsy
Conditions
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.
Interventions
DRUGPhenobarbital
Phenobarbital will be given based on weight range
OTHERPlacebo
Placebo group
Sponsors
University of Toledo Health Science Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Determine tolerance of medication using the depression, cognitive and sleepiness screening tools listed above | Screening, 3 months, final visit |
Countries
United States
Outcome results
None listed