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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000572
• EU PAS number:
  EUPAS1000000572
• Study ID:
  1000000572
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  This is a non-interventional, prospective study in subjects with a diagnosis of FOS (with or without FBTCS), for whom the treating physician has made the decision to initiate perampanel as monotherapy.; Subjects will be identified by sites from the electronic/paper medical and pharmacy records of patients attending their usual epilepsy clinic. ; The clinical decision to initiate perampanel as monotherapy will already have been made before the subject is identified for the study – ie, the decision to add perampanel is independent of the decision to enroll the subject in the study. ; Before any study procedures, signed informed consent/assent form must be first obtained (or, in the case of children, the legal representative will sign consent on behalf of the subject). ; Subjects will then enter into Screening Period for eligibility determination. Demography and medical history (including epilepsy history and baseline seizure frequency based on retrospective collection from 3 months before Day 0 [day of first dose of perampanel]) will be collected. ; Subjects who have provided informed consent to participate in sleep measurements will also be provided with a HARU 1 wearable device and instructed in its use for recording of baseline sleep parameters. ; Subjects who are eligible will then enter the Treatment Period and perampanel monotherapy will be initiated. During the Treatment Period, data will be collected prospectively via 2 types of assessments: on site and off site.
• Study status:
  Ongoing

Research institutions and networks

Institutions

International University of Health and Welfare Hospital, Narita

Science Tokyo
Ochiai Neurological Clinic
Tokyo Women's Medical University, Adachi Medical Center
Itami City Hospital
Toho University Sakura Hospital
TMG Asaka Medical Center
Kagoshima University
SHINJUKU NEURO CLINIC
NHO Nagasaki Medical Center
Medical corporation Seishoukai Minato Hospital
Kurume University
Yokohama Minoru Epilepsy & Developmental Clinic
Koide Clinic of Epilepsy and Neurological Disorders
Fukuoka Sanno Hospital

Study timelines

Date when funding contract was signed

Planned: 30/04/2021

Actual: 30/04/2021

Study start date

Planned: 30/04/2021

Actual: 30/04/2021

Data analysis start date

Planned: 10/12/2024

Actual: 02/12/2024

Date of final study report

Planned: 23/04/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eisai Co., Ltd.

Study protocol

Initial protocol

e2007-m081-515--pcs2_afterCRAB_v3_FINAL.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

UMIN000044131

UMIN-CTR PORTABLE Study