Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1

NCT07563881 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: RAP-219-FOS-301
• Study Type: interventional
• Target: 333
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures. This study is being conducted to determine if RAP-219 is safe and effective in reducing focal seizure frequency.

Conditions

Focal Seizure; Epilepsy; Focal Epilepsy

Keywords

Focal Preserved Consciousness; Focal Impaired Consciousness

Outcome Measures

Primary Outcomes (1)

• Median Percent Change in Seizure Frequency

  Median percent change in seizure frequency and ≥ 50% seizure frequency reduction responder rates:

  End of double-blind treatment period (end of week 14) vs Baseline

Secondary Outcomes (2)

• ≥50% seizure frequency reduction responder rates

  End of double-blind treatment period (end of week 14) vs Baseline.

• Longest Seizure Free Interval

  Across the entire 14-week double-blind treatment period

Other Outcomes (1)

• RAP-219 safety and tolerability

  From Visit 1 through End of Study, on average Week 22.

Study Arms (3)

Active Arm- High Dose

EXPERIMENTAL

RAP-219 daily tablets administered orally

Drug: RAP-219

Active Arm- Medium Dose

EXPERIMENTAL

RAP-219 daily tablets administered orally

Drug: RAP-219

Placebo

PLACEBO COMPARATOR

Inert comparator matching the active treatment

Other: Placebo

Interventions

RAP-219 DRUG

RAP-219 high dose tablets administered orally daily

Active Arm- High Dose

Placebo OTHER

Matching placebo tablets administered orally daily

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 75
• BMI 18-45 kg/m2
• Diagnosis of focal epilepsy for ≥24 months prior to Visit 1
• Report from at least 1 brain MRI or CT scan and 1 EEG study, each completed within 10 years prior to Visit 1, consistent with focal epilepsy diagnosis
• Concomitant use of between 1 and 3, inclusive, antiseizure medication(s) ASM(s) as maintenance, not including rescue or pro re nata (PRN) ASMs
• Ability to keep accurate daily focal seizure records using an e-diary

You may not qualify if:

• Known hypersensitivity or prior exposure to RAP-219.
• Unstable or uncontrolled serious medical, neurologic (other than focal epilepsy), or psychiatric condition that is ongoing or considered likely to recur
• Anticipated need for surgery during the study period
• Medical history of any of the following:
• generalized epilepsy
• focal preserved consciousness without observable manifestations (also known as focal aware nonmotor) as the participant's only seizure type
• psychogenic nonepileptic seizure (PNES)
• status epilepticus or seizure clusters (when individual seizures cannot be counted) within 12 months prior to Visit 1 (Day -56).
• epilepsy surgery within 12 months prior to Visit 1 (Day -56).
• Participation in another clinical study of an investigational product within 12 weeks or 5 half-lives of this other investigational product

Sponsors & Collaborators

• Rapport Therapeutics Inc.: lead

MeSH Terms

Conditions

Seizures; Epilepsy; Epilepsies, Partial

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Central Study Contacts

Rapport Medical

CONTACT

857 323 9048; RAP-219-FOS@rapportrx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a placebo-controlled trial of active drug versus placebo.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share