CLINICAL TRIALS PROFILE FOR CENOBAMATE
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All Clinical Trials for CENOBAMATE
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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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. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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