Recruiting NCT06590896
Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cenobamate.
- Who it may be relevant to
- Registry conditions: Epilepsies, Partial. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Multicenter Open-Label Extension Study to Evaluate the Long-term Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures
Overview
To evaluate the long-term safety and tolerability of cenobamate in Japanese epilepsy patients with partial seizures
Interventions
- Drug Cenobamate
Cenobamate will be orally administered once daily.
Primary outcome measures
- Incidences of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Through study completion, an average of 4 years]
- Urinalysis(pH) [Time frame: Through study completion, an average of 4 years]
- Urinalysis(Specific Gravity) [Time frame: Through study completion, an average of 4 years]
- Urinalysis(Protein) [Time frame: Through study completion, an average of 4 years]
- Urinalysis(Glucose) [Time frame: Through study completion, an average of 4 years]
- Urinalysis(Ketone) [Time frame: Through study completion, an average of 4 years]
- Urinalysis(Bilirubin) [Time frame: Through study completion, an average of 4 years]
- Urinalysis(Blood) [Time frame: Through study completion, an average of 4 years]
- Urinalysis(Nitrite) [Time frame: Through study completion, an average of 4 years]
- Urinalysis(Urobilinogen) [Time frame: Through study completion, an average of 4 years]
Secondary outcome measures (1)
- Percentage Change in all partial seizure frequency per 28-Day [Time frame: Through study completion, an average of 4 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 29 centers
- Ehime University Hospital — Ehime
- Department of Neurology and Stroke Center, Southern Tohoku Clinic. — Fukushima
- Hiroshima University Hospital — Hiroshima
- NHO Kure Medical Center and Chugoku Cancer Center — Hiroshima
- Asahikawa Medical University Hospital — Hokkaido
- Itami City Hospital — Hyōgo
- JA-Ibaraki Tsuchiura Kyodo General Hospital — Ibaraki
- University of Tsukuba Hospital — Ibaraki
- … and 21 more centers
Identifiers
NCT: NCT06590896 · ONO-2017-02 · jRCT2031220198