Cenobamate Expanded Access Program (EAP)

NCT04513860 | Unknown

• 1 other identifier: C013, C017, C021 EAP
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This Cenobamate Expanded Access Program (EAP) is designed to continue providing treatment with Cenobamate (YKP3089) to patients with partial-onset epilepsy that were enrolled in the SK Life Science clinical trial YKP3089C013, YKP3089C017 or YKP3089C021.

Conditions

Partial Epilepsy

Keywords

Partial onset seizures; Treatment resistant; Partial epilepsy

Interventions

YKP3089 DRUG

Capsule, dose to be titrated Tablet, dose to be titrated

Also known as: Cenobamate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients currently enrolled in one of the following SK life science studies: YKP3089C013, YKP3089C017 or YKP3089C021.
• Patient who is currently pregnant and enrolled in one of the following SK life science studies: YKP3089C013, YKP3089C017 or YKP3089C021 may enter the EAP program.
• Written informed consent signed by the patient or legal guardian prior to entering the EAP in accordance with the ICH GCP guidelines. If the written informed consent is provided by the legal guardian because the patient is unable to do so, a written or verbal consent from the patient must also be obtained.

You may not qualify if:

• \. Patients that have previously discontinued for any reason from studies YKP3089C013, YKP3089C017 and YKP3089C021.

Sponsors & Collaborators

• SK Life Science, Inc.: lead

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Cenobamate

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Marc Kamin, MD

  SK Life Science, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 14, 2020
• Last Updated: January 26, 2022

Record last verified: 2022-01