Clinical trial NCT05533814: A Study to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Participants With Focal Onset Seizures With or Without Focal to Bilateral Tonic-clonic Seizures
Official title: A Multicenter, Open-Label, Prospective Study With an Extension Phase to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Subjects With Focal Onset Seizures With or Without Focal to Bilateral Tonic-Clonic Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Keywords: Epilepsy
Focal onset seizures
Focal to bilateral tonic-clonic seizures
Fycompa
Seizures
Monotherapy
Open-label
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-09
Enrollment: 125
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the efficacy of perampanel monotherapy measured by the seizure-free rate during the Maintenance Period (24 weeks) of the Treatment Phase in untreated participants with focal onset seizures (FOS) with or without focal to bilateral tonic-clonic seizures (FBTCS).

Detailed description: The study will consist of a Core Study (36 weeks) and an Extension Phase (24 weeks). Core Study will consist of 4 weeks Pre-treatment Phase or Baseline and 32 weeks Treatment Phase (8 weeks Titration period and 24 weeks Maintenance period).

Eligibility criteria: Inclusion Criteria:

1. Male and female, age 4 years or older
2. Diagnosis of epilepsy with FOS with or without FBTCS according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (2017), established by clinical history and an electroencephalogram (EEG)
3. Newly diagnosed or recurrent epilepsy with at least 2 unprovoked seizures (excluding focal non-motor seizures) separated by a minimum of 24 hours in the 1 year before Visit 1 (baseline)

Exclusion Criteria:

1. Focal non-motor seizures only
2. Generalized epilepsies or seizures such as absences and/or myoclonic seizures, or Lennox Gastaut syndrome
3. History of status epilepticus within 1 year before Visit 1 (baseline)
4. History of psychogenic non-epileptic seizures within 5 years before Visit 1 (baseline)
5. Progressive central nervous system (CNS) disease (including degenerative CNS diseases, progressive tumors, and dementia), or clinically significant psychological or neurological disorders
6. History of suicidal ideation/attempt within 5 years before Visit 1 (baseline)
7. Evidence of clinically significant active hepatic disease, or other clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigators could affect the participant safety or interfere with the study assessments
8. History of any type of brain or central nervous system surgery within 1 year before Visit 1 (baseline)
9. Newly started ketogenic diet or has been on ketogenic diet for less than 5 weeks before Visit 1 (baseline)
10. Multiple drug allergies or a severe drug reaction to anti-epileptic drugs (AEDs), including dermatological (example, Stevens-Johnson syndrome), hematological, or organ toxicity reactions
11. Hypersensitive to perampanel or ingredients of this drug
12. Participant with genetic problems including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
13. Use of intermittent rescue medication on 2 or more occasions within 4 weeks before Visit 1 (baseline)
14. History of receiving any AED (except for occasional use less than 2 weeks of AEDs as rescue treatment), antipsychotics, or anti-anxiety drugs within 12 weeks before Visit 1 (baseline)
15. History of receiving any AED (including rescue treatment) for more than 2 weeks in total within 2 years before Visit 1 (baseline)
16. Has received prior treatment with perampanel
17. Females of child bearing potential who are breastfeeding or pregnant at Visit 1 (baseline), or who do not consent to employ contraception
18. Currently enrolled in another clinical study or have used any investigational drug/biologics or device within 28 days or 5\*half-life, whichever is longer
19. Participant who did not consent to having at least 2 weeks of washout period before Visit 2, if known to take Cytochrome P4503A (CYP3A) inducing drugs or foods on Visit 1 (including, but not limited to the following) - Carbamazepine, enzalutamide, mitotane, phenytoin, phenobarbital, amobarbital, secobarbital, rifabutin, rifampicin, food containing St. John's Wort (hypericum perforatum), bosentan, efavirenz, etravirine, modafinil, armodafinil, rufinamide, nevirapine, oxcarbazepine, and glucocorticoid (except for topical use)

Primary outcomes:
measure: Percentage of Participants Who Will Achieve Seizure Freedom During the 24-weeks Maintenance Period
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Percentage of Participants Who Will Achieve Seizure Freedom During the Total 48-weeks Treatment Period (24-weeks Maintenance Period Plus 24-weeks Extension Phase)
timeFrame: Up to 48 weeks
measure: Percentage of Participants With at Least 50 Percent (%) and 75% Reduction in Seizure Frequency During the 24-weeks Maintenance Period
timeFrame: Up to 24 weeks
measure: Percentage of Participants With at Least 50% and 75% Reduction in Seizure Frequency During the 24-weeks Extension Phase
timeFrame: Up to 24 weeks
measure: Median Percent Change From Baseline in Partial Onset Seizure Frequency per 28 Days at the End of 8 Weeks Titration Period
timeFrame: Baseline up to Week 8 of Titration Period
measure: Median Percent Change From Baseline in Partial Onset Seizure Frequency per 28 days at the End of 24 Weeks Maintenance Period
timeFrame: Baseline up to Week 24 of Maintenance Period
measure: Median Percent Change From Baseline in Partial Onset Seizure Frequency per 28 days at the End of 24 Weeks Extension Phase
timeFrame: Baseline up to Week 24 of Extension Phase
measure: Percentage of Participants Remaining on Perampanel Treatment at the end of Maintenance Period
timeFrame: Week 24 of Maintenance Period
measure: Percentage of Participants Remaining on Perampanel Treatment at the end of Extension Phase
timeFrame: Week 24 of Extension Phase
measure: Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 60 weeks
measure: Number of Participants With Abnormal Vital Sign Values
timeFrame: Up to 60 weeks
measure: Number of Participants With Clinically Significant Laboratory Values
timeFrame: Up to 60 weeks
Other outcomes:
Locations:
city: Cheongju
country: Korea, Republic of
facility: Eisai Site #9
city: Daegu
country: Korea, Republic of
facility: Eisai Site #4
city: Daegu
country: Korea, Republic of
facility: Eisai Site #8
city: Daejeon
country: Korea, Republic of
facility: Eisai Site #3
city: Jeonju
country: Korea, Republic of
facility: Eisai Site #10
city: Seoul
country: Korea, Republic of
facility: Eisai Site #1
city: Seoul
country: Korea, Republic of
facility: Eisai Site #2
city: Seoul
country: Korea, Republic of
facility: Eisai Site #5
city: Seoul
country: Korea, Republic of
facility: Eisai Site #6
city: Seoul
country: Korea, Republic of
facility: Eisai Site #7
Study officials:
References: