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Pilot Study of Add-On Fycompa (perampanel) Treatment for Catamenial Epilepsy

  • Status
    Accepting Candidates
  • Age
    N/A
  • Sexes
    All
  • Healthy Volunteers
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Description

The procedures of this study include clinical measurements to assess seizure frequency, a questionnaire to determine the risk of hurting yourself, as well as the collection of blood and urine for a pregnancy test, and completing a daily diary to record seizures and menstruation. The time frame for this study is 120 days and includes 3 study visits to the University of Florida Jacksonville and 3 telephone calls from your home.

After you consent and enroll in the study. You will chart your menstrual cycle and seizures for 2 months to set a baseline. After the 2-month period, you will be randomized (like a flip of a coin) into one of two parallel treatment groups.

Group 1:聽 Fycompa 4 mg daily

Group 2:聽 Fycompa 4 mg daily with a boost of 8 mg daily a week before the start of your menstruation cycle until Day 4 of your cycle.

During the treatment phase, you will continue to chart your menstrual cycle and seizures for 2 months. You will be contacted by phone on a monthly basis to verify compliance with charting, treatment, and to monitor for any adverse effects. You will continue taking any anticonvulsant medication doses this will not be changed during the baseline or treatment study period.

Details

Protocol number IRB202102694

Eligibility

Inclusion:

鈥� Female

鈥� 8-45 years old

鈥� Diagnosis of focal epilepsy

鈥� =2 seizures per month

鈥� Regular menstrual cycle

鈥� Increase in seizures during menses

Study visits: 3 clinic visits at the University of Florida Jacksonville over a duration of 120 days (4 months).

Exclusion:

鈥� Progressive neurologic or systemic disorder

鈥� Use of systemic hormonal contraception during 3 months prior to enrollment (however, subjects with a progestin-releasing IUD who still have monthly periods may be enrolled)

鈥� Women on system hormonal contraception will be excluded as these women are not ovulatory

鈥� Subject is pregnant or breastfeeding

鈥� Active suicidal or homicidal ideation

鈥� Decisionally impaired or comatose individuals.

Lead researcher

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    1

    Contact the research team

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  2. Step
    2

    Get screened to confirm eligibility

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    Provide your consent to participate

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  4. Step
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