Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
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| ClinicalTrials.gov Identifier: NCT01397968 |
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Recruitment Status :
Completed
First Posted : July 20, 2011
Results First Posted : April 11, 2022
Last Update Posted : April 11, 2022
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Sponsor:
SK Life Science, Inc.
Information provided by (Responsible Party):
SK Life Science, Inc.
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Partial Epilepsy | Drug: YKP3089 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 222 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2 Multicenter, Double-blind, Randomized, Adjunctive, Placebo-controlled Trial With an Open-label Extension to Evaluate the Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures |
| Actual Study Start Date : | July 6, 2011 |
| Actual Primary Completion Date : | June 2013 |
| Actual Study Completion Date : | January 28, 2021 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: YKP3089 |
Drug: YKP3089
Capsule, dose to be titrated Tablet, dose to be titrated
Other Name: cenobamate |
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo capsule Placebo tablet |
Primary Outcome Measures :
- Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days [ Time Frame: assessed per 28 days during 12 week period; change from baseline and 12 weeks reported ]Percent change in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline
Secondary Outcome Measures :
- 50% Responder Rate [ Time Frame: 12 weeks ]Greater than or equal to 50% reduction in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of treatment resistant partial epilepsy;
- History of epilepsy for at least 2 years;
- Have at least 3 simple partial with motor component, complex partial or secondarily generalized seizures per month with no consecutive 21 day seizure free period.
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Currently treated on a stable dose of :
- 1 - 3 AED's for at least 12 weeks prior to randomization.
- VNS will not be counted as AED; however the parameters must remain stable for at least 4 weeks prior to baseline.
- Benzodiazepines taken at least once per week for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED. Therefore only a maximum of two additional approved AEDs will be allowed.
Exclusion Criteria:
- A history of alcoholism, drug abuse, or drug addiction within the past 2 years.
- Subject has had status epilepticus within past 1 year.
- Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED.
- Subjects taking felbamate with less than 18 months continuous exposure.
- Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs.
- No active suicidal plan/intent or active suicidal thoughts in the past 6 months.
- History of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt.
- Subject meets criteria for current major depressive episode (within 6 months).
- Use of intermittent rescue benzodiazepines more than once/month (1-2 doses in a 24-hour period is considered one rescue) in the one month period prior to Visit 1.
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): NCT01397968
Locations
Show 38 study locations
Sponsors and Collaborators
SK Life Science, Inc.
Investigators
| Study Director: | Marc Kamin, MD | SK Life Science, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | SK Life Science, Inc. |
| ClinicalTrials.gov Identifier: | NCT01397968 |
| Other Study ID Numbers: |
YKP3089C013 |
| First Posted: | July 20, 2011 Key Record Dates |
| Results First Posted: | April 11, 2022 |
| Last Update Posted: | April 11, 2022 |
| Last Verified: | April 2022 |
Keywords provided by SK Life Science, Inc.:
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partial onset seizures treatment resistant partial epilepsy |
Additional relevant MeSH terms:
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Epilepsy Seizures Epilepsies, Partial Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Cenobamate Anticonvulsants |