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Last Updated: August 14, 2020

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CLINICAL TRIALS PROFILE FOR CENOBAMATE

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All Clinical Trials for cenobamate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03234699 Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs as a Means of Predicting Drug-drug Interactions Completed SK Life Science Phase 1 2017-02-22 This study is aimed to investigate the influence of cenobamate on the activity of CYP3A4/5, CYP2B6, CYP2C19, and CYP2C9 by using drugs recommended by both the FDA and EMA as in vivo probes. In order to avoid a potential pharmacokinetic interaction between the probes, midazolam (CYP3A), warfarin (CYP2C9), and omeprazole (CYP2C19) will be administered together as a validated cocktail and separately from bupropion (CYP2B6) using an adequate washout time period between the 2 assessments. The starting daily dose of cenobamate will be 12.5 mg, which will be administered for 2 weeks. Then, daily cenobamate doses will be increased every 2 weeks to 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg. The CYP probes will be tested before cenobamate administration, at steady state at 100mg/day of cenobamate for midazolam only and finally at steady state at 200mg/day of cenobamate for all CYP probes. The results of this DDI study will provide a basis to make appropriate dose recommendation for a safe use of concomitant drugs with cenobamate using these isoenzymes in their metabolic pathway.
NCT03509285 A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users Completed SK Life Science Phase 1 2017-03-08 This randomized, single-dose, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of cenobamate in recreational drug users with sedative drug use experience. In the Qualification phase, subjects will receive a single dose of either alprazolam or placebo in a crossover design, with a wash-out period of at least 24 hours between treatments. Subjects who are clearly able to distinguish the positive control from placebo will be enrolled in the Treatment phase and will be randomized to single oral doses of cenobamate (2 dose levels), alprazolam (2 dose levels), and placebo in a double-blind, double-dummy, 5-way crossover design. Washout-periods between the 5 treatment periods in the Treatment phase will be at least 16 days.
NCT03678753 Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures Recruiting SK Life Science, Inc. Phase 3 2018-09-21 This trial is intended to study the safety and effectiveness of an new anti-epileptic drug (AED) on Primary Generalized Tonic-Clonic (PGTC) Seizures. Eligible Subjects will continue to take their usual AEDs and receive either cenobamate or placebo. Subjects will have a 50% chance or receiving cenobamate or placebo (sugar pill). Subjects will initially receive 12.5 mg of cenobamate or placebo (study drug) and increase the dose every two weeks until they reach a target dose of 200 mg. Subjects will take study drug at approximately the same time in the morning (once a day) with or without food. If tolerability issues arise, dosing can be changed to evening. Also, once a subject reaches 200 mg of study drug, the dose can be decreased one time to 150 mg, if necessary. The treatment period is 22 weeks and there is a 3 week follow up period, which includes a one week decrease in study drug to 100 mg prior to stopping. Subjects who complete may be eligible for an extension study and will not have to complete the follow up period. Subjects will track their seizure types and frequency in a diary throughout the study.
NCT03961568 Cenobamate Open-Label Extension Study for YKP3089C025 Not yet recruiting SK Life Science, Inc. Phase 3 2019-05-01 52 Week Open-Label Safety Study of Cenobamate for Subjects who Complete YKP3089C025
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for cenobamate

Condition Name

Condition Name for cenobamate
Intervention Trials
Primary Generalized Epilepsy 1
Healthy Volunteer 1
Healthy 1
Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy 1
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Condition MeSH

Condition MeSH for cenobamate
Intervention Trials
Seizures 2
Epilepsy, Generalized 2
Epilepsy 2
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Clinical Trial Locations for cenobamate

Trials by Country

Trials by Country for cenobamate
Location Trials
United States 14
Canada 1
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Trials by US State

Trials by US State for cenobamate
Location Trials
Kansas 2
Washington 1
Pennsylvania 1
New York 1
Minnesota 1
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Clinical Trial Progress for cenobamate

Clinical Trial Phase

Clinical Trial Phase for cenobamate
Clinical Trial Phase Trials
Phase 3 2
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for cenobamate
Clinical Trial Phase Trials
Completed 2
Not yet recruiting 1
Recruiting 1
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Clinical Trial Sponsors for cenobamate

Sponsor Name

Sponsor Name for cenobamate
Sponsor Trials
SK Life Science, Inc. 2
SK Life Science 2
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Sponsor Type

Sponsor Type for cenobamate
Sponsor Trials
Industry 4
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