Fycompa for Catamenial Epilepsy

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Catamenial EpilepsyFycompa - Drug
Eligibility
18 - 50
Female
What conditions do you have?
Select

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.

Eligible Conditions
  • Catamenial Epilepsy

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Baseline

Baseline
Responder rate (percent of patients experiencing a 50% or greater reduction in seizures) relative to baseline seizure frequencies

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Fycompa 4 mg daily with a boost of 8 mg
1 of 3
Fycompa 4 mg daily with a boost to 6 mg daily
1 of 3
Fycompa 4 mg daily
1 of 3

Active Control

Experimental Treatment

55 Total Participants · 3 Treatment Groups

Primary Treatment: Fycompa · No Placebo Group · Phase 4

Fycompa 4 mg daily
Drug
Experimental Group · 1 Intervention: Fycompa · Intervention Types: Drug
Fycompa 4 mg daily with a boost of 8 mg
Drug
ActiveComparator Group · 1 Intervention: Fycompa with a boost · Intervention Types: Drug
Fycompa 4 mg daily with a boost to 6 mg daily
Drug
ActiveComparator Group · 1 Intervention: Fycompa with a boost · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fycompa
2017
N/A
~6330

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline

Who is running the clinical trial?

University of FloridaLead Sponsor
1,250 Previous Clinical Trials
698,698 Total Patients Enrolled
Eisai Inc.Industry Sponsor
506 Previous Clinical Trials
145,004 Total Patients Enrolled
Katherine Zarroli, MDPrincipal InvestigatorUniversity of Florida

Eligibility Criteria

Age 18 - 50 · Female Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing and able to comply with scheduled visits and study procedures.
You have ≥2 unprovoked seizures per month despite drug trials with ≥1 first-line AEDs.