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Last Updated: May 26, 2022

CLINICAL TRIALS PROFILE FOR CENOBAMATE


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All Clinical Trials for Cenobamate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01397968 ↗ Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures Unknown status SK Life Science Phase 2 2011-05-01 This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs. Also to evaluate the safety and tolerability of YKP3089.
NCT01397968 ↗ Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures Unknown status SK Life Science, Inc. Phase 2 2011-05-01 This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs. Also to evaluate the safety and tolerability of YKP3089.
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.
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, Inc. 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cenobamate

Condition Name

Condition Name for Cenobamate
Intervention Trials
Partial Epilepsy 3
Healthy 2
Healthy Volunteer 1
Hepatic Impairment 1
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Condition MeSH

Condition MeSH for Cenobamate
Intervention Trials
Seizures 6
Epilepsy 3
Epilepsies, Partial 3
Epilepsy, Generalized 2
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Clinical Trial Locations for Cenobamate

Trials by Country

Trials by Country for Cenobamate
Location Trials
United States 40
Poland 14
Ukraine 10
India 5
Bulgaria 3
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Trials by US State

Trials by US State for Cenobamate
Location Trials
Maryland 5
California 3
Pennsylvania 3
Florida 3
Kentucky 2
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Clinical Trial Progress for Cenobamate

Clinical Trial Phase

Clinical Trial Phase for Cenobamate
Clinical Trial Phase Trials
Phase 3 4
Phase 2 1
Phase 1 5
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Clinical Trial Status

Clinical Trial Status for Cenobamate
Clinical Trial Phase Trials
Recruiting 3
Completed 3
Active, not recruiting 1
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Clinical Trial Sponsors for Cenobamate

Sponsor Name

Sponsor Name for Cenobamate
Sponsor Trials
SK Life Science, Inc. 10
SK Life Science 3
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Sponsor Type

Sponsor Type for Cenobamate
Sponsor Trials
Industry 13
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