Trial Outcomes & Findings for Fycompa in Catamenial Epilepsy (NCT NCT05201703)

NCT ID: NCT05201703

Last Updated: 2024-07-31

Results Overview

To measure the 50% responder rate will be analyzed using Chi square analysis.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 7 participants
• Primary outcome timeframe: Baseline (2 months) and treatment (2 months)
• Results posted on: 2024-07-31

Participant Flow

• 1 subject was excluded from the study due to a positive C-SSRS. * 2 subjects were excluded during the baseline period (1 subject did not have her menstrual period during the baseline period so dropped out due to irregular menses and 1 subject did not have any seizures during the baseline phase).

Participant milestones

Measure	Fycompa 4 mg Daily Fycompa: Fycompa 4 mg daily	Fycompa 4 mg Daily With a Boost to 6 mg Daily Fycompa with a boost: 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.
Overall Study STARTED	1	3
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Fycompa 4 mg Daily Fycompa: Fycompa 4 mg daily	Fycompa 4 mg Daily With a Boost to 6 mg Daily Fycompa with a boost: 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.
Overall Study Did not understand how to boost medication despite counseling; did not boost	0	1
Overall Study Subject did not tolerate the treatment (perampanel) due to mild side effects so exited the study.	0	1

Baseline Characteristics

Fycompa in Catamenial Epilepsy

Baseline characteristics by cohort

Measure	Fycompa 4 mg Daily n=1 Participants Fycompa: Fycompa 4 mg daily	Fycompa 4 mg Daily With a Boost to 6 mg Daily n=3 Participants Fycompa with a boost: 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.	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	36.5 years n=5 Participants	31.7 years n=7 Participants	33.6 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (2 months) and treatment (2 months)

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

To measure the 50% responder rate will be analyzed using Chi square analysis.

Outcome measures

Measure	Fycompa 4 mg Daily n=1 Participants Fycompa: Fycompa 4 mg daily	Fycompa 4 mg Daily With a Boost to 6 mg Daily n=1 Participants Fycompa with a boost: 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.
Responder Rate (Percent of Patients Experiencing a 50% or Greater Reduction in Seizures) Relative to Baseline Seizure Frequencies	1 Participants	1 Participants

Adverse Events

Fycompa 4 mg Daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fycompa 4 mg Daily With a Boost to 6 mg Daily

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fycompa 4 mg Daily n=1 participants at risk Fycompa: Fycompa 4 mg daily	Fycompa 4 mg Daily With a Boost to 6 mg Daily n=3 participants at risk Fycompa with a boost: 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.
Nervous system disorders Feeling off	0.00% 0/1 • 4 months per participant assessment (2 months of baseline and 2 months of treatment)	33.3% 1/3 • Number of events 1 • 4 months per participant assessment (2 months of baseline and 2 months of treatment)

Additional Information

Dr. Katherine Zarroli

University of Florida - Jacksonville

Phone: 3025615456

Email: katherine.zarroli@jax.ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60