Catamenial EpilepsyPhase 4NCT05201703

Fycompa in Catamenial Epilepsy

A Phase 4 study testing Fycompa and Fycompa with a boost in people with Catamenial Epilepsy, run by University of Florida at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of the proposed investigation is to carry out a pilot study of add-on perampanel (Fycompa) in women with perimenstural (C1) catamenial epilepsy. Perampanel, a noncompetitive AMPA receptor antagonist, is uniquely positioned to decrease progesterone receptor mediated excitotoxicity. Read more about this study

Who is it for?: Ages 18 to 50 years, women only
Conditions the study is for: Catamenial Epilepsy
What is being tested?: Fycompa and Fycompa with a boost
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 9 Mar 2022to 15 Dec 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
No healthy volunteers
Adult

Who may be able to join

Female
Diagnosis of focal onset seizures (FOS) i. Established by clinical history and an EEG ii. Patients with a normal EEG may be included if they met other diagnostic criteria based on clinical history
Presumably ovulatory women based on menstrual cycles of 21-35 days from beginning of menstrual flow to the beginning of the next menses
≥18-50 years old
≥2 unprovoked seizures per month despite drug trials with ≥1 first-line anti-epileptic drugs (AED)
Seizures must show a C1 catamenial pattern in 2 of 3 documented cycles i. C1 pattern will be defined as a two-fold increase in average daily seizure frequency during the menstrual phase, as compared to the follicular and luteal phases of the ovulation cycle, in 2 of 3 documented cycles. The menstrual phase will be defined as days -3 to +3 of the menstrual cycle (where onset of menstruation is defined as day 1) (Herzog et al, 1997). Of note, in the NIH Progesterone Trial, the level of catameniality was 1.69 based on Herzog et al. (1997) criteria though this trial will use a level of 2 to include women only with high levels of perimenstrual catamenial exacerbation.
Willingness and ability to comply with scheduled visits and study procedures

Who cannot join

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
Comatose individuals.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida
Jacksonville, Florida, 32209

Other trials in United States

About this study

Official title: Pilot Study of Add-On Fycompa (Perampanel)Treatment for Catamenial Epilepsy

Conditions: Catamenial Epilepsy
Being tested: Fycompa, Fycompa with a boost

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FycompaDrug
Also called Perampanel
Fycompa 4 mg daily
Fycompa with a boostDrug
Also called Perampanel
Fycompa 4 mg daily with a boost to 6 mg daily a week before the start of your menstruation cycle until Day 4 of your cycle.

Study groups in NCT05201703
Study group	Role	What they receive
Fycompa 4 mg daily	Experimental	Not described Receives: Drug: Fycompa
Fycompa 4 mg daily with a boost to 6 mg daily	Active comparator	Not described Receives: Drug: Fycompa with a boost

What is being measured

The primary outcome is the main question the study is designed to answer.

Responder Rate (Percent of Patients Experiencing a 50% or Greater Reduction in Seizures) Relative to Baseline Seizure Frequencies
To measure the 50% responder rate will be analyzed using Chi square analysis.
Measured: Baseline (2 months) and treatment (2 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 202215 Dec 2023

First posted21 Jan 2022
Study start9 Mar 2022
Primary completion15 Dec 2023
Study completion15 Dec 2023

Why it stopped: Poor enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Catamenial EpilepsyStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05201703
Sponsor's protocol ID: IRB202102694
Status last verified: Jul 2024
First submitted: 7 Jan 2022
Last updated: 31 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Add-On Fycompa (Perampanel)Treatment for Catamenial Epilepsy
ClinicalTrials.gov ID: NCT05201703
Acronym / sponsor ID: IRB202102694
Conditions: Catamenial Epilepsy
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Poor enrollment
Enrolment: 7 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: Eisai Inc.
Study start: 9 Mar 2022 (actual)
Primary completion: 15 Dec 2023 (actual)
Study completion: 15 Dec 2023 (actual)
First posted: 21 Jan 2022 (actual)
Results: Posted 31 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fycompa 4 mg daily	Experimental	Drug: Fycompa
Fycompa 4 mg daily with a boost to 6 mg daily	Active comparator	Drug: Fycompa with a boost

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Female
Diagnosis of focal onset seizures (FOS) i. Established by clinical history and an EEG ii. Patients with a normal EEG may be included if they met other diagnostic criteria based on clinical history
Presumably ovulatory women based on menstrual cycles of 21-35 days from beginning of menstrual flow to the beginning of the next menses
≥18-50 years old
≥2 unprovoked seizures per month despite drug trials with ≥1 first-line anti-epileptic drugs (AED)

Key exclusion criteria (6 listed)

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)
Subject is pregnant or breastfeeding
Active suicidal or homicidal ideation
Comatose individuals.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FycompaAlso: PerampanelFycompa 4 mg daily	Drug	Fycompa 4 mg daily
Fycompa with a boostAlso: PerampanelFycompa 4 mg daily with a boost to 6 mg daily a week before the start of your menstruation cycle until Day 4 of your cycle.	Drug	Fycompa 4 mg daily with a boost to 6 mg daily

Primary outcome

Responder Rate (Percent of Patients Experiencing a 50% or Greater Reduction in Seizures) Relative to Baseline Seizure Frequencies
Time frame: Baseline (2 months) and treatment (2 months)
To measure the 50% responder rate will be analyzed using Chi square analysis.

Results and safety

Results posted to the registry on 31 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fycompa 4 mg Daily	1	1
Fycompa 4 mg Daily With a Boost to 6 mg Daily	3	1

Primary outcome: Responder Rate (Percent of Patients Experiencing a 50% or Greater Reduction in Seizures) Relative to Baseline Seizure Frequencies

Time frame: Baseline (2 months) and treatment (2 months). Count of participants. Unit: Participants

Measure	Fycompa 4 mg Daily n = 1	Fycompa 4 mg Daily With a Boost to 6 mg Daily n = 1
Value	1	1

Population analysed: Statistics unable to be performed due to low sample size.

Adverse events

Time frame: 4 months per participant assessment (2 months of baseline and 2 months of treatment). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fycompa 4 mg Daily	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Fycompa 4 mg Daily With a Boost to 6 mg Daily	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Katherine Zarroli, MD principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fycompa and Fycompa with a boost in people with Catamenial Epilepsy, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Responder Rate (Percent of Patients Experiencing a 50% or Greater Reduction in Seizures) Relative to Baseline Seizure Frequencies (time frame: Baseline (2 months) and treatment (2 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05201703.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024; AzTrials last refreshed its copy on 30 Oct 2026.