Catamenial Epilepsy
Conditions
Brief 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.
Interventions
DRUGFycompa
Fycompa 4 mg daily
DRUGFycompa 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.
Sponsors
Eisai Inc.
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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) a. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate (Percent of Patients Experiencing a 50% or Greater Reduction in Seizures) Relative to Baseline Seizure Frequencies | Baseline (2 months) and treatment (2 months) | To measure the 50% responder rate will be analyzed using Chi square analysis. |
Countries
United States
Participant flow
Pre-assignment details
* 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).
Participants by arm
| Arm | Count |
|---|---|
| Fycompa 4 mg Daily Fycompa: Fycompa 4 mg daily | 1 |
| 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. | 3 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | Fycompa 4 mg Daily | Fycompa 4 mg Daily With a Boost to 6 mg Daily | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Continuous | 36.5 years | 31.7 years | 33.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 1 participants | 3 participants | 4 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 3 |
| other Total, other adverse events | 0 / 1 | 1 / 3 |
| serious Total, serious adverse events | 0 / 1 | 0 / 3 |
Outcome results
Primary
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.
Time frame: Baseline (2 months) and treatment (2 months)
Population: Statistics unable to be performed due to low sample size.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fycompa 4 mg Daily | Responder Rate (Percent of Patients Experiencing a 50% or Greater Reduction in Seizures) Relative to Baseline Seizure Frequencies | 1 Participants |
| Fycompa 4 mg Daily With a Boost to 6 mg Daily | Responder Rate (Percent of Patients Experiencing a 50% or Greater Reduction in Seizures) Relative to Baseline Seizure Frequencies | 1 Participants |