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Trial record 51 of 146 for:    epilepsy AND Bethesda

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 : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
SK Life Science, Inc.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 13, 2019
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

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 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).
Drug: Cenobamate
active drug
Other Name: YKP3089




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Hawaii
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States, 96814
United States, Maine
Maine Medical Center
Scarborough, Maine, United States, 04074
United States, Maryland
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States, 20817
United States, New York
Five Towns Neuroscience Research
Woodmere, New York, United States, 11598
Sponsors and Collaborators
SK Life Science, Inc.

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Responsible Party: SK Life Science, Inc.
ClinicalTrials.gov Identifier: NCT03961568     History of Changes
Other Study ID Numbers: YKP3089C033
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SK Life Science, Inc.:
Idiopathic Generalized Epilepsy
Additional relevant MeSH terms:
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Epilepsy
Seizures
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms