Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Patients With Partial Onset Seizures (Including Secondarily Generalized Seizures)
- Conditions
- Partial Onset Seizures
- Registration Number
- JPRN-jRCT2080223588
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
Monotherapy treatment with perampanel at doses of 4 mg and 8 mg was effective in achieving seizure-free status for at least 26 weeks in untreated subjects with POS. Monotherapy treatment with perampanel at doses of 4 mg and 8 mg was safe and well tolerated. No new safety signals were identified for monotherapy treatment with perampanel.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 89
(1)Be considered reliable and willing to be available for the study period and are able to record seizures and report adverse events (AEs) himself/herself or have a caregiver who can record seizures and report AEs for them
(2)Participants who are newly diagnosed or recurrent epilepsy
(3)Participants who have excluded the progressive central nervous system (CNS) abnormality occurring seizures by computed tomography (CT) or magnetic resonance imaging (MRI)
(4)Participants who have had a diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures
(1)Participants who present only simple partial seizures without motor signs
(2)Participants who have seizure clusters where individual seizures cannot be counted
(3)Participants who present or have a history of Lennox-Gastaut syndrome
(4)Participants who have a history of status epilepticus
(5)Participants who have a history of psychogenic non-epileptic seizures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Primary Outcome: The seizure-free rate during 26-week Maintenance Period
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>Secondary Outcome: The seizure-free rate in the 52-week treatment