Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy
Purpose
This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine if RAP-219 works and is safe in patients with Refractory Focal Epilepsy.
Condition
- Focal Onset Seizures
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Medically refractory focal epilepsy with an implanted responsive neurostimulator device placed correctly in a seizure onset zone that meet several device-related criteria and demonstrated history of compliance with interrogation of the RNS device and upload of data - If currently treated with antiseizure medications, up to a maximum of 4 concomitant mediations are allowed - At least 1 clinical seizure during the 8-week retrospective eligibility period - Participants in otherwise good health as determined by the investigator - Willing and able to adhere to all aspects of the protocol - A demonstrated history of compliance with interrogation of the RNS device and upload of data before screening
Exclusion Criteria
- Participants with generalized onset seizures in the past 10 years - History of status epilepticus while on antiseizure medications within 2 years of screening - Individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods - Participants who have had epilepsy surgery within the last 12 months before screening
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental RAP-219 |
Participants will receive 0.75 mg RAP-219 daily for 5 days followed by 1.25 mg RAP-219 daily for the remainder of the 8-week treatment period. |
|
Recruiting Locations
University of Texas Health Science Center, Houston
Houston, Texas 77030
Houston, Texas 77030
University of Texas Health Science Center, Houston Mayo Clinic
Rochester, Minnesota 55905
Rochester, Minnesota 55905
More Details
- Status
- Recruiting
- Sponsor
- Rapport Therapeutics Inc.
Detailed Description
This is a Phase 2A, proof-of-concept, multi-center, open-label study designed to evaluate the efficacy, safety, tolerability, and PK/PD relationship of RAP-219 in adult participants with refractory focal epilepsy. The activity of RAP-219 will be assessed in approximately 20 participants treated with the RNS® system.