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Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures

NCT ID: NCT06590896

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-04

Study Completion Date

2027-01-31

Brief Summary

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To evaluate the long-term safety and tolerability of cenobamate in Japanese epilepsy patients with partial seizures

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Detailed Description

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Conditions

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Epilepsies, Partial

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cenobamate

Group Type EXPERIMENTAL

Cenobamate

Intervention Type DRUG

Cenobamate will be orally administered once daily.

Interventions

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Cenobamate

Cenobamate will be orally administered once daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects completed Study YKP3089C035 by SK Life Science.

Exclusion Criteria

* Subjects that have previously discontinued for any reason from the Core study (YKP3089C035).
* Any significant changes to the medical history of the subject that in the opinion of the investigator, could affect the safety of the subject.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Project Leader

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

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Ehime University Hospital

Ehime, , Japan

Site Status RECRUITING

Department of Neurology and Stroke Center, Southern Tohoku Clinic.

Fukushima, , Japan

Site Status RECRUITING

Hiroshima University Hospital

Hiroshima, , Japan

Site Status RECRUITING

NHO Kure Medical Center and Chugoku Cancer Center

Hiroshima, , Japan

Site Status RECRUITING

Asahikawa Medical University Hospital

Hokkaido, , Japan

Site Status RECRUITING

Itami City Hospital

Hyōgo, , Japan

Site Status RECRUITING

JA-Ibaraki Tsuchiura Kyodo General Hospital

Ibaraki, , Japan

Site Status RECRUITING

University of Tsukuba Hospital

Ibaraki, , Japan

Site Status RECRUITING

Kagoshima University Hospital

Kagoshima, , Japan

Site Status RECRUITING

Tanaka Neurosurgical Clinic

Kagoshima, , Japan

Site Status RECRUITING

St. Marianna University School of Medicine Hospital

Kanagawa, , Japan

Site Status RECRUITING

Yokohama City University Hospital

Kanagawa, , Japan

Site Status RECRUITING

Kumamoto Ezuko Rehabilitation Medical Center

Kumamoto, , Japan

Site Status RECRUITING

NHO Nagasaki Medical Center

Nagasaki, , Japan

Site Status RECRUITING

Koide Clinic of Epilepsy and Neurological Disorders

Osaka, , Japan

Site Status RECRUITING

Osaka University Hospital

Osaka, , Japan

Site Status RECRUITING

Shintokukai Nii Neurosurgery and Psychiatry Clinic

Osaka, , Japan

Site Status RECRUITING

Ochiai Brain Clinic

Saitama, , Japan

Site Status RECRUITING

TMG ASAKA Medical Center

Saitama, , Japan

Site Status RECRUITING

Sakurai Clinic

Shiga, , Japan

Site Status RECRUITING

NHO Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, , Japan

Site Status RECRUITING

Seirei Hamamatsu General Hospital

Shizuoka, , Japan

Site Status RECRUITING

Seirei Mikatahara General Hospital

Shizuoka, , Japan

Site Status RECRUITING

Jichi Medical University Hospital

Tochigi, , Japan

Site Status RECRUITING

Tokushima University Hospital

Tokushima, , Japan

Site Status RECRUITING

Medical Hospital, Tokyo Medical and Dental University

Tokyo, , Japan

Site Status RECRUITING

National Center of Neurology and Psychiatry

Tokyo, , Japan

Site Status RECRUITING

Tokyo Medical University Hospital

Tokyo, , Japan

Site Status RECRUITING

NHO Yamagata National Hospital

Yamagata, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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North America Clinical Trial Support Desk

Role: CONTACT

[email protected]
+18665877745(Toll-Free)

International Clinical Trial Support Desk

Role: CONTACT

[email protected]
+17162141777(Standard)

Other Identifiers

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jRCT2031220198

Identifier Type: REGISTRY

Identifier Source: secondary_id

ONO-2017-02

Identifier Type: -

Identifier Source: org_study_id

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