Cenobamate Open-Label Extension Study for YKP3089C025

Sponsor

SK Life Science, Inc. (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03961568

Collaborator

(none)

130

Enrollment

Locations

Arms

50.6

Anticipated Duration (Months)

3.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

52 Week Open-Label Safety Study of Cenobamate for Subjects who Complete YKP3089C025

Condition or Disease	Intervention/Treatment	Phase
Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy	Drug: Cenobamate	Phase 3

Detailed Description

52 Week Open-Label Safety Study of cenobamate adjunctive therapy for subjects who complete double-blind study YKP3089C025. Subjects will have a 12 week double-blind conversion phase where subjects who received placebo in the double-blind study will be converted to cenobamate. Subjects who received cenobamate in the double-blind study will continue to receive their daily dose of cenobamate. Subjects switching from placebo to cenobamate will be titrated starting at 12.5 mg and increase their dose over the course of 12 weeks as followes 12.5 mg for 2 weeks, 25 mg for two weeks, 50 mg for two weeks, 100 mg for two weeks, 150 mg for two weeks, and 200 mg for two weeks. All subjects will receive 200 mg for the last two weeks of the conversion phase to preserve the blind. After completing the doubl-blind conversion phase, subjects will have 40 weeks of open-label, flexibly dosed cenobamate. The dose range is 50 mg - 200 mg. Primary endpoints are all safety measures.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Aug 13, 2019

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Cenobamate active drug Other Names: 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).	Drug: Cenobamate active drug Other Names: YKP3089

Arm

Intervention/Treatment

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.

Drug: Cenobamate

active drug

Other Names:

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).

Drug: Cenobamate

active drug

Other Names:

YKP3089

Outcome Measures

Primary Outcome Measures

Incidence of Adverse Events and SAEs [386 +/- 2 days]
Summary statistics for clinical laboratory test results and vital signs; and physical examination, neurologic examination and electrocardiogram (ECG) finding.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The subject must have successfully completed the Double-blind Treatment Period in the Core study.
Written informed consent signed by the subject or legal guardian, prior to entering the study, in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained. As required by country-specific regulations, only the subject may sign the ICF in accordance with ICH guidelines.

Exclusion Criteria:

Subject tests positive, via urine drug screen at Visit 14 of the Core study, for illicit drugs except for tetrahydrocannabinol and Cannabinoids.
Any significant changes to the subject's medical history that, in the opinion of the Principal Investigator, could affect the subject's safety or conduct of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego (UCSD)	La Jolla	California	United States	92093
2	The Neurology Research Group, LLC.	Miami	Florida	United States	33176
3	University of South Florida	Tampa	Florida	United States	33606
4	Hawaii Pacific Neuroscience	Honolulu	Hawaii	United States	96814
5	Consultants in Epilepsy and Neurology, PLLC	Boise	Idaho	United States	83702
6	Maine Medical Center	Scarborough	Maine	United States	04074
7	Mid-Atlantic Epilepsy and Sleep Center	Bethesda	Maryland	United States	20817
8	Minneapolis Clinic of Neurology	Golden Valley	Minnesota	United States	55422
9	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19140
10	Valley Medical Center	Renton	Washington	United States	98057
11	MultiCare Rockwood Neurology Center	Spokane	Washington	United States	99204
12	Multiprofile Hospital for Active Treatment Puls AD	Blagoevgrad		Bulgaria	2700
13	Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD	Sofia		Bulgaria	1407
14	Diagnostic Consultative Center Neoclinic EAD	Sofia		Bulgaria	1408
15	Diagnostic Consultative Center Equita EOOD	Varna		Bulgaria	9000
16	Medical Center Medica Plus OOD	Veliko Tarnovo		Bulgaria	5000
17	Multiprofile Hospital for Active Treatment Sv. Ivan Rilski Gorna Oryahovitsa EOOD	Veliko Tarnovo		Bulgaria	5100
18	Cerebrovaskularni poradna	Ostrava-Poruba		Czechia	708 52
19	Fakultni nemocnice v Motole	Praha 5		Czechia	150 06
20	Forbeli s.r.o.-Neurologicka ambulance	Praha 6		Czechia	160 00
21	Neurologicka ambulance	Zlín		Czechia	760 01
22	Semmelweis Egyetem I. Sz. Gyermekgyogyaszati Klinika	Budapest		Hungary	1083
23	Centrum Leczenia Padaczki i Migreny	Kraków	Malopolskie	Poland	31-209
24	Centrum Medyczne Pratia Warszawa	Warszawa	Mazowieckie	Poland	01-868
25	Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach	Katowice	Silesia	Poland	40-635
26	Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia Medic-R sp. k.	Poznań	Wielkopolskie	Poland	60-848
27	MUDr. Beata Dupejova, neurologicka ambulancia, s.r.o.	Banská Bystrica		Slovakia	974 04
28	IN MEDIC s.r.o.	Bardejov		Slovakia	085 01
29	Konzilium, s.r.o.	Dubnica Nad Váhom		Slovakia	018 41
30	Municipal Institution "Dnipropetrovsk City Clinical Hospital No16" of Dnipropetrovsk Regional Council	Dnepropetrovsk	Dnipropetrovsk	Ukraine	49027
31	Municipal Institution Odesa Regional Clinical Hospital, Department of Cerebro-Vascular Diseases	Odesa	Odessa	Ukraine	65025
32	Regional Clinical Center of Neurosurgery and Neurology "Uzhhorod National University"	Úzhgorod	Zakarpattia	Ukraine	88018
33	Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council	Zaporozhye	Zaporizhzhya	Ukraine	69600
34	Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnikov", Regional Center	Dnipropetrovs'k		Ukraine	49005
35	Municipal Institution "Dnipropetrovsk Regional Clinical Hospital named after I. I. Mechnikov"	Dnipropetrovs'k		Ukraine	49005
36	Regional Psyconeurology Hospital #3	Ivano-Frankivs'k		Ukraine	76011
37	Communal Non-Commercial Enterprise of Kharkiv Regional Council	Kharkiv		Ukraine	61068
38	Municipal Institution of Lviv Regional Council	Lviv		Ukraine	79010
39	Ternopil Regional Municipal Psychoneurological Hospital	Ternopil'		Ukraine	46020
40	Municipal Institution "Vinnytsia Regional Psychoneurological Hospital named after Acad. O.I. Yushch	Vinnytsya		Ukraine	21005

Sponsors and Collaborators

SK Life Science, Inc.

Investigators

Study Director: Marc Kamin, MD, SK Life Science, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SK Life Science, Inc.

ClinicalTrials.gov Identifier:

NCT03961568

Other Study ID Numbers:

YKP3089C033

First Posted:

May 23, 2019

Last Update Posted:

May 24, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by SK Life Science, Inc.

Idiopathic Generalized Epilepsy

Additional relevant MeSH terms:

Epilepsy

Seizures

Epilepsy, Generalized

Cenobamate

Study Results

No Results Posted as of May 24, 2022