NCT07219407

Brief Summary

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 RAP-219 Long- term safety and open-label antiseizure activity in patients with Refractory Focal Epilepsy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
20mo left

Started Dec 2025

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Dec 2025Feb 2028

First Submitted

Initial submission to the registry

October 8, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 21, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2028

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

October 8, 2025

Last Update Submit

January 22, 2026

Conditions

Focal EpilepsyEpilepsySeizureRefractory Focal EpilepsyFocal SeizureFocal Onset Seizure

Keywords

Focal SeizuresEpilepsyRNSLong episode

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment-emergent adverse events (TEAEs)

    From the start of RAP-219 treatment through 8 weeks after last dose, up to Week 112

Secondary Outcomes (13)

  • Percent change in clinical seizure frequency

    Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.

  • Clinical seizure 25%, 50%, 75%, and 100% responder proportions

    Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.

  • Change in clinical seizure-free day frequency

    Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.

  • Longest clinical seizure-free interval

    Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.

  • Time to pre-randomization clinical seizure count

    Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.

  • +8 more secondary outcomes

Study Arms (1)

RAP-219

EXPERIMENTAL
Drug: RAP-219

Interventions

RAP-219DRUG

Participants will receive one RAP-219 0.125 mg capsule daily for 3 days followed by one 0.25mg tablet RAP-219 daily for 28 days, then one 0.75mg tablet daily for the remainder of the treatment period.

RAP-219

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Consultants in Epilepsy and Neurology, PLLC

Boise, Idaho, 83702, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

NYU Langone Comprehensive Epilepsy Center

New York, New York, 10016, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

University of Pennsylvania - Department of Neurology

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 770300, United States

RECRUITING

MeSH Terms

Conditions

Epilepsies, PartialEpilepsySeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Imran Quraishi, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Moreno

CONTACT

(857) 323-9048dmoreno@rapportrx.com

Beth Bowers

CONTACT

(857) 323-9048bbowers@rapportrx.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2025

First Posted

October 21, 2025

Study Start

December 15, 2025

Primary Completion (Estimated)

February 3, 2028

Study Completion (Estimated)

February 3, 2028

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

US(7)