A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds

Recruiting Phase 3 Interventional Study
Partial Epilepsy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Ono Pharmaceutical Co., Ltd. · Industry
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About This Trial

Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Japanese male or female patients aged 2 to under 18 years at the time of informed consent. * Patients diagnosed with epilepsy as having POS with uncontrolled seizures at least 6 months prior to informed consent, regardless of the presence or absence of secondarily generalized …
Contacts

North America Clinical Trial Support Desk

+18665877745 (Toll-Free)

clinical_trial@ono-pharma.com

CONTACT

International Clinical Trial Support Desk

+17162141777 (Standard)

clinical_trial@ono-pharma.com

CONTACT