A Trial of the Efficacy and Safety of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures

Study Identifier
CVL-865-SZ-001
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Plain Language Summary
Available Language(s): English, Korean, Polish, Serbian, Spanish, Ukrainian

Study Details

Medical Condition
  • Neuroscience - Other
  • Study Drug
  • Placebo
  • CVL-865
  • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 75 Years

    Protocol Summary

    The goal of this clinical trial is to learn if CVL-865, when taken regularly with other anti-seizure medicines, works to prevent seizures in adults with drug-resistant focal onset seizures. It will also learn about the safety of CVL-865.

    The main question it aims to answer is whether CVL-865, when taken regularly with other anti-seizure medicines, lowers the number of seizures in those with a diagnosis of epilepsy with drug-resistant focal onset seizures.

    This study has an 8-week Screening/Baseline Period, a 13-week Treatment Period (including a 2-week Titration Phase, an 8-week Maintenance Phase, and a 3-week Taper Phase), and a 4-week Safety Follow-Up Period.

    Participants will take CVL-865 or a placebo twice a day during the 10-13 week Treatment Period, visit the clinic every few weeks for checkups, tests, and surveys, and fill out an e-Diary.

    Study Locations

    Location
    Status
    Location
    Little Rock, Arkansas
    Little Rock, Arkansas, United States, 72205
    Status
    Not applicable
    Location
    Downey, California
    Downey, California, United States, 90242
    Status
    Not applicable
    Location
    Loma Linda, California
    Loma Linda, California, United States, 92354
    Status
    Not applicable
    Location
    Valencia, California
    Valencia, California, United States, 91355
    Status
    Not applicable
    Location
    New Haven, Connecticut
    New Haven, Connecticut, United States, 06520
    Status
    Not applicable
    Location
    Altamonte Springs, Florida
    Altamonte Springs, Florida, United States, 32714
    Status
    Not applicable
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