Long-term RAP-219 treatment for adults with focal onset seizures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, open-label, long-term extension enrolling adults with refractory focal seizures who completed the parent RAP-219-FOS-201 study. Participants will receive RAP-219 and undergo regular safety, tolerability, pharmacokinetic, and pharmacodynamic monitoring, along with tracking of seizure activity. Stable RNS system settings and regular device data uploads are required to document seizure outcomes. The study focuses on gathering extended safety data and observing any sustained antiseizure effects in a real-world, monitored setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Completion of the associated parent study (RAP-219-FOS-201) treatment period with acceptable tolerability, per Investigator.
* Diagnosis of refractory focal epilepsy
* Stable RNS(c) system settings
* A demonstrated history of compliance with RNS(c) system data interrogation and upload
* Good overall health other than focal epilepsy, per Investigator.
* BMI ≥ 18 kg/m\^2 and ≤ 45 kg/m\^2
* Willing and able to adhere to all aspects of the protocol.

Exclusion Criteria:

* Known of hypersensitivity to RAP-219
* Any clinically unstable or serious medical, neurological (other than epilepsy), psychological, or behavioral problem; laboratory or ECG finding that would increase participant risk or should otherwise exclude the patient from participation, as assessed by Investigator
* Pregnancy, lactation, or individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods

Where it's running

• Consultants in Epilepsy and Neurology, PLLC
  Boise, Idaho, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• NYU Langone Comprehensive Epilepsy Center
  New York, New York, United States Recruiting
• Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting
• University of Pennsylvania - Department of Neurology
  Philadelphia, Pennsylvania, United States Recruiting
• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Imran Quraishi, MD — Yale University
• Study coordinator: Daniela Moreno
• Email: dmoreno@rapportrx.com
• Phone: (857) 323-9048

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• RAP-219 for adults with focal seizures

  This study tests whether RAP-219 can reduce how often focal seizures happen in adults with focal epilepsy, compared with a placebo.

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• RAP-219 in adults with focal seizures

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• Vascular risk screening and management after late-onset seizures

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• Detecting thalamus seizures using a Percept deep brain stimulator

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.