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
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.