Trials / Terminated
TerminatedNCT05201703
Fycompa in Catamenial Epilepsy
Pilot Study of Add-On Fycompa (Perampanel)Treatment for Catamenial Epilepsy
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- University of Florida · Academic / Other
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
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. This mechanism of action would allow a novel use of perampanel as an effective treatment of C1 catamenial epilepsy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fycompa | Fycompa 4 mg daily |
| DRUG | 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. |
Timeline
- Start date
- 2022-03-09
- Primary completion
- 2023-12-15
- Completion
- 2023-12-15
- First posted
- 2022-01-21
- Last updated
- 2024-07-31
- Results posted
- 2024-07-31
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05201703. Inclusion in this directory is not an endorsement.