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REALIZE - Trial of a new treatment for drug-resistant focal epilepsy

Focal Epilepsy

The REALIZE study is a placebo-controlled clinical trial designed to test the effectiveness, safety and tolerability of investigational drug CVL-865, given as an oral pill, as a treatment for drug-resistant focal onset epilepsy.  Participants will be randomly assigned to receive either CVL-865 or placebo, in addition to the medications they are already taking.  The study aims to determine whether CVL-865 is effective in reducing seizure frequency compared to participants receiving placebo.

Participants who complete the study have the option to join an “open-label” extension study, in which all participants receive the investigational drug.

Category
Trial Status
Recruiting
Trial Phase
Phase 2 Drug Trial
Registry Listing
Trial contact details
Contact Person
Delphine Lévy-Bencheton
Email
What you need to know

Who can take part?

  • Males and females aged 18 to 75 years, who have been diagnosed with focal onset, focal aware, focal impaired awareness, and focal to bilateral tonic-clonic seizures for at least 2 years
  • People with 4 or more seizures per month
  • People who have failed to achieve seizure control with at least 2 prior antiepileptic drugs
  • People taking certain medications may be ineligible to participate – discuss with the study team
  • Participants of childbearing potential must avoid pregnancy during the study

What is involved for you?

  • CVL-865 or placebo taken as an oral pill, twice a day
  • MRI or CT scan
  • Keep a seizure diary
  • Questionnaires
  • Physical exams and vital signs
  • Neurological exams
  • Electrocardiogram
  • Blood tests
  • Urine tests

Trial dates

This trial is accepting participants until April 2023.

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