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Fycompa for Catamenial Epilepsy
Phase 4
Recruiting
Led By Katherine Zarroli, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Study Summary
This trial will test if the drug perampanel can help women with perimenstrual epilepsy by reducing excitotoxicity, which is when neurons are overexcited and die.
Who is the study for?
This trial is for women aged 18-50 with catamenial epilepsy, which worsens around their menstrual period. They must have regular cycles and focal onset seizures that haven't improved despite trying at least one anti-seizure medication. Women can't join if they're using hormonal birth control, are pregnant or breastfeeding, have a progressive illness, or are experiencing severe mental health crises.Check my eligibility
What is being tested?
The study tests Fycompa (perampanel), an AMPA receptor antagonist thought to reduce seizure activity related to hormone changes during the menstrual cycle. Some participants will receive an additional boost of Fycompa to assess its effectiveness in treating seizures that coincide with menstruation.See study design
What are the potential side effects?
Fycompa may cause dizziness, sleepiness, fatigue, irritability and aggression. It might also affect coordination and balance leading to falls or gait disturbances. There's a risk of serious psychiatric side effects like suicidal thoughts or behavior.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Responder rate (percent of patients experiencing a 50% or greater reduction in seizures) relative to baseline seizure frequencies
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Fycompa 4 mg dailyExperimental Treatment1 Intervention
Group II: Fycompa 4 mg daily with a boost to 6 mg dailyActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fycompa
2017
N/A
~6330
Find a Location
Who is running the clinical trial?
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,965 Total Patients Enrolled
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,650 Total Patients Enrolled
Katherine Zarroli, MDPrincipal InvestigatorUniversity of Florida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are between 18 and 50 years old.Women who have regular periods that come every 21 to 35 days.You are currently thinking about harming yourself or someone else.People who are in a deep unconscious state.You have been diagnosed with focal onset seizures, confirmed by your medical history and an EEG test.If you have seizures, they need to follow a specific pattern during your menstrual cycle.You have a worsening condition affecting your brain or body.You have two or more seizures each month, even after trying at least one type of common seizure medication.
Research Study Groups:
This trial has the following groups:- Group 1: Fycompa 4 mg daily
- Group 2: Fycompa 4 mg daily with a boost to 6 mg daily
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential hazards accompany the usage of Fycompa?
"Power has rated Fycompa's safety a 3; as this is a Phase 4 drug, it has already been approved by the necessary regulatory bodies."
Answered by AI
What is the maximum capacity of participants taking part in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this research trial which was initially posted on March 9th 2022 is presently recruiting participants. 55 people are needed from one medical centre for the study's completion."
Answered by AI
Are there any vacancies within this trial for potential participants?
"Affirmative. Clinicaltrials.gov suggests that this medical trial is currently open for enrolment, having been posted on March 9th 2022 and recently edited on October 5th 2022. There are 55 prospective participants required from a single location."
Answered by AI
Are individuals aged 40 and above being sought out for inclusion in this trial?
"This experiment is seeking patients aged 18 to 50, with 103 studies intended for minors and 155 trials targeting those over 65."
Answered by AI
Could I be included in this investigation?
"Eligible candidates for this trial must demonstrate symptoms of aura and be between the ages 18-50. The medical team is looking to enroll approximately 55 people."
Answered by AI
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