Cenobamate Open-Label Extension Study for YKP3089C025
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03961568|
Recruitment Status : Enrolling by invitation
First Posted : May 23, 2019
Last Update Posted : December 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy||Drug: Cenobamate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Open-Label Extension Study to Evaluate the Long-Term Safety of Cenobamate Adjunctive Therapy in Subjects With Primary Generalized Tonic-Clonic Seizures|
|Actual Study Start Date :||August 13, 2019|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||November 2023|
Experimental: Core Study Placebo
Subjects who did not receive Cenobamate in the Core Study will receive Cenobamate 12.5 mg tablet once a day for two weeks, 25 mg tablet once a day for two weeks, 50 mg tablet once a day for two weeks, 100 mg tablets once a day for two weeks, 150 mg tablets once a day for two weeks and 200 mg tablets once a day for twelve weeks.
Other Name: YKP3089
Experimental: Core Study Active
Subjects who received cenobamate in the Core study will continue to receive the same daily dose (150 mg or 200mg).
Other Name: YKP3089
- Incidence of Adverse Events and SAEs [ Time Frame: 386 +/- 2 days ]Summary statistics for clinical laboratory test results and vital signs; and physical examination, neurologic examination and electrocardiogram (ECG) finding.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961568