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RAP-219 for Partial Seizures

Phase 2
Recruiting
Led By Jaqueline A French, MD
Research Sponsored by Rapport Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 1 clinical seizure during the 8-week retrospective eligibility period
Be older than 18 years old
Must not have
Participants with generalized onset seizures in the past 10 years
History of status epilepticus while on antiseizure medications within 2 years of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening until 5 months after enrollment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called RAP-219 in patients with Refractory Focal Epilepsy to see if it is effective and safe for treating the condition.

Who is the study for?
This trial is for adults with Refractory Focal Epilepsy who have not responded well to other treatments. Participants can be on up to four seizure medications and must have an implanted neurostimulator device that meets specific criteria. They should have had at least one seizure in the past 8 weeks, be in good health overall, and able to follow the study's procedures.
What is being tested?
The trial is testing RAP-219, a new drug for people with difficult-to-treat seizures. The goal is to see if it's effective and safe when used alongside current epilepsy treatments.
What are the potential side effects?
Potential side effects of RAP-219 are not detailed here but typically could include reactions similar to other antiseizure medications such as dizziness, fatigue, gastrointestinal issues or changes in mood or behavior.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had at least one seizure in the last 8 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had seizures that affect both sides of my brain in the last 10 years.
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I have had a severe seizure despite medication within the last 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~dosing until 5 months after dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and dosing until 5 months after dosing for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy in reducing frequency of RNS-recorded long episodes in participants with FOS
Secondary study objectives
Change in seizure severity
Global Impression of Change
Measurement of Clinical Seizure Frequency
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: RAP-219Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Rapport Therapeutics Inc.Lead Sponsor
Jaqueline A French, MDPrincipal InvestigatorNYU Langone Comprehensive Epilepsy Center
~10 spots leftby Mar 2025
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