Status:
UNKNOWN
Prospective Open-label Evaluation of Cenobamate Adjunctive Treatment of Adults With Refractory Focal Epilepsy
Lead Sponsor:
Mid-Atlantic Epilepsy and Sleep Center, LLC
Conditions:
Focal Epilepsy
Eligibility:
All Genders
18-70 years
Brief Summary
To evaluate the efficacy, safety and tolerability of cenobamate as adjunctive treatment of refractory focal epilepsy
Detailed Description
The purpose of the study is to evaluate efficacy and safety of adjunctive cenobamate treatment of adults with drug-resistant focal epilepsy in "real world" clinical setting, providing "real world expe...
Eligibility Criteria
Inclusion
- Age 18-70
- Focal epilepsy uncontrolled in spite of past or present treatment with four or more anti-seizure drugs (ASDs), with focal aware motor seizures, focal unaware seizures and focal to bilateral tonic clonic seizures.
- Stable ASD doses for at least 30 days
- Epilepsy duration for ≥ 2 years
- Past/current treatment with ≥ 4 ASDs. VNS, RNS and DBS treatment will be allowed and will not count as an ASD. VNS, RNS and DBS setting must be stable for 3 months prior to enrollment.
- Seizure frequency of ≥1/month for ≥ 10/12 months before treatment initiation
Exclusion
- Primary generalized epilepsy
- Focal aware non-motor seizures without bilateral tonic-clonic seizures
- Non-epileptic seizures
- Progressive neurological disease including neoplasm, CNS degenerative disorders including Alzheimer's disease
- Any systemic illness or unstable medical condition that might pose additional risk, including renal or liver disease, clinically uncontrolled cardiac disease other unstable metabolic or endocrine disturbances, and active systemic cancer
- Change in the dose of any ASD within 30 days prior to enrollment
- Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements
- Pregnancy
- Use of any CNS-active investigational drugs within 1 month of enrollment
- Resective epilepsy surgery less than 6 months before study initiation
- Vagal nerve stimulator VNS, RNS or DBS implantation less than 6 months before study initiation
- Adjustment of VNS, RNS or DBS settings less than 3 months before study initiation
- Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Key Trial Info
Start Date :
June 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04879433
Start Date
June 25 2020
End Date
November 30 2023
Last Update
August 11 2022
Active Locations (1)
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1
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States, 20817