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IRB needs updated
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Phenobarbital - dose based by weight range |
|
| 2 | Placebo Comparator | Placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenobarbital | Drug | Phenobarbital will be given based on weight range |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Determine tolerance of medication using the depression, cognitive and sleepiness screening tools listed above | Screening, 3 months, final visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lazar J Greenfield, Jr, MD, PhD | University of Toledo Health Science Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Toledo, Health Science Campus | Toledo | Ohio | 43606 | United States |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010634 | Phenobarbital |
| ID | Term |
|---|---|
| D001463 | Barbiturates |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Placebo |
| Other |
Placebo group |
|
| D006571 |
| Heterocyclic Compounds |