Prospective Open-label Evaluation of Cenobamate Adjunctive Treatment of Adults With Refractory Focal Epilepsy

NCT04879433 | Unknown

• 1 other identifier: maesc010
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy, safety and tolerability of cenobamate as adjunctive treatment of refractory focal epilepsy

Conditions

Focal Epilepsy

Keywords

cenobamate,; adjunctive therapy; focal epilepsy

Outcome Measures

Primary Outcomes (5)

• The seizure frequency per 28 days.

  comparing seizure frequency per 28 day periods during maintanance treatment vs. baseline

  seizure count per 28 days, baseline 52 weeks, maintanance period 52 weeks

• seizure freedom rate

  rate of seizure-free patients

  52 weeks of adjunctive cenobamate maintanance treatment

• >75% seizure frequency reduction

  rate of patients with \>75% seizure frequency reduction, comparing seizure frequency per 28 day periods during maintanance treatment vs. baseline

  seizure count per 28 days, baseline 52 weeks, maintanance period 52 weeks

• treatment emergent adverse events rate

  rate of treatment emergent adverse events

  52 weeks of baseline period; whole treatment period

• treatment discontinuation rate

  rate of cenobamate treatment discontinuation

  52 weeks of baseline period; whole treatment period

Secondary Outcomes (6)

• median seizure frequency reduction

  52 weeks of baseline period; 52 weeks of adjunctive cenobamate maintanance treatment

• median seizure frequency reduction

  52 weeks of baseline period; the whole treatment period

• seizure severity

  52 weeks of baseline period; 52 weeks of adjunctive cenobamate maintanance treatment

• quality of life change

  52 weeks of baseline period; the whole treatment period

• seizure-related injuries

  52 weeks of baseline period; the whole treatment period

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female adults aged 18-70 with uncontrolled focal epilepsy

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mid-Atlantic Epilepsy and Sleep Center, LLC: lead

Study Sites (1)

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20817, United States

RECRUITING

MeSH Terms

Conditions

Epilepsies, Partial

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: May 10, 2021
• Study Start: June 25, 2020
• Primary Completion: June 25, 2023
• Study Completion: November 30, 2023
• Last Updated: August 11, 2022

Record last verified: 2022-08

Locations

US (1)