Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy

Rapport Therapeutics Inc.

Status and phase: Enrolling; Phase 2

Conditions: Focal Onset Seizures

Treatments: Drug: RAP-219

Study type: Interventional

Funder types: Industry

Identifiers

NCT06377930

RAP-219-FOS-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

RAP-219

Experimental group

Description:

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.

Treatment:

Drug: RAP-219