An Open-label, Observational, Prospective, Multicenter Study to Evaluate the LOng-teRm Efficacy and SafeTy of PerAmpanel as Monotherapy in SuBjects Age 4 Years and Older with FocaL Onset Seizures:PORTABLE Study

An Open-label, Observational, Prospective, Multicenter Study to Evaluate the LOng-teRm Efficacy and SafeTy of PerAmpanel as Monotherapy in SuBjects Age 4 Years and Older with FocaL Onset Seizures:PORTABLE Study - An Open-label, Observational, Prospective, Multicenter Study to Evaluate the LOng-teRm Efficacy and SafeTy of PerAmpanel as Monotherapy in SuBjects Age 4 Years and Older with FocaL Onset Seizures:PORTABLE Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044131

Enrollment

Registered

2021-05-23

Start date

2021-06-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients diagnosed with Focal Onset Seizures

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Male or female, age 4 years or older at the time of informed consent (in the case of minors, consent from a legal representative [eg, one parent] is required) 2) Diagnosed with FOS (with or without FBTCS) according to International League Against Epilepy (ILAE) 2017 classification 3) Newly diagnosed or recurrent epilepsy. For subjects with recurrent epilepsy, they must have relapsed at least 2 years after the end of the last antiepileptic drug (AED) treatment. 4) Subjects for whom the decision to initiate perampanel has been made, according to the judgment of the investigator

Exclusion criteria

Exclusion criteria: 1) A history of receiving any AED (including AED used as rescue treatment) for more than 2 weeks in total within 2 years 2) Previously treated with perampanel at any time 3) A history of hypersensitivity to any of the excipients of perampanel 4) Severe hepatic impairment(Child-Pugh Score:C) 5) Subjects who have participated in a study involving administration of an investigational drug/biologics or device within 4 weeks 6) Not appropriate for the study according to the judgment of the investigator

Design outcomes

Primary

Measure	Time frame
To evaluate 24-month seizure freedom in response	—

Secondary

Measure	Time frame
Secondary Objectives: 1. To evaluate the treatment effectiveness as measured by pragmatic seizure free rate in response to perampanel monotherapy at 6, 12, 18 and 30 months 2. To evaluate the treatment effectiveness as measured by sustained seizure freedom in response to perampanel monotherapy at 12 and 24 months 3. To evaluate 6, 12, 18, 24 and 30 months retention on perampanel 4. To evaluate the impact of perampanel monotherapy on the subject's quality of life (QOL) (i.e.EQ-5D-5L, VAS and PedsQL) from the baseline to the specific time points 5.To evaluate safety of perampanel monotherapy Exploratory Objectives: 1. To explore the impact of perampanel monotherapy on sleep-related data from the baseline 2. To evaluate the treatment adherence of perampanel 3. To explore clinical factors that influence seizure freedom	—

Measure

Time frame

Secondary Objectives: 1. To evaluate the treatment effectiveness as measured by pragmatic seizure free rate in response to perampanel monotherapy at 6, 12, 18 and 30 months 2. To evaluate the treatment effectiveness as measured by sustained seizure freedom in response to perampanel monotherapy at 12 and 24 months 3. To evaluate 6, 12, 18, 24 and 30 months retention on perampanel 4. To evaluate the impact of perampanel monotherapy on the subject's quality of life (QOL) (i.e.EQ-5D-5L, VAS and PedsQL) from the baseline to the specific time points 5.To evaluate safety of perampanel monotherapy Exploratory Objectives: 1. To explore the impact of perampanel monotherapy on sleep-related data from the baseline 2. To evaluate the treatment adherence of perampanel 3. To explore clinical factors that influence seizure freedom

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Countries

Japan

Contacts

Public ContactTomoaki Sakaguchi

Linical Co. ,Ltd. Contract Medical Affairs Unit, Clinical Trial Operations

sakaguchi-tomoaki@linical.com03-6215-8005

Outcome results