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(904) 244-0411

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

  • Status
    Accepting Candidates
  • Age
    N/A
  • Sexes
    All
  • Healthy Volunteers
I'm interested
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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:  Fycompa 4 mg daily

Group 2:  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:

• Female

• 8-45 years old

• Diagnosis of focal epilepsy

• =2 seizures per month

• Regular menstrual cycle

• 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:

• Progressive neurologic or systemic disorder

• 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)

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

• Subject is pregnant or breastfeeding

• Active suicidal or homicidal ideation

• Decisionally impaired or comatose individuals.

Lead researcher

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.