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NCT Number: NCT07219407

A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures

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.

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Key information

Conditions

Focal Epilepsy Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Focal Onset Seizure Focal Seizure Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Refractory Focal Epilepsy Seizure Seizures Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Consultants in Epilepsy and Neurology, PLLC, Boise, Idaho, United States

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About this study

This is a multi-center, open-label study to evaluate the long-term safety, tolerability, pharmacokinetics, pharmacodynamics and antiseizure activity of RAP-219 in adult participants with refractory focal seizures

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

RAP-219

Drug

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.

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs)

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

Secondary outcomes

  1. Percent change in clinical seizure frequency

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

    Group median percent change in clinical seizure frequency per 28-day period as reported in a clinical seizure diary

  2. Clinical seizure 25%, 50%, 75%, and 100% responder proportions

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

    Proportion of participants with at least 25%, 50%, 75%, or with 100% reduction in clinical seizure frequency per 28-day period as reported in a clinical seizure diary

  3. Change in clinical seizure-free day frequency

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

    Group median change in clinical seizure-free day frequency per 28-day period as reported in a clinical seizure diary

  4. Longest clinical seizure-free interval

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

    Duration, in days, of the longest continuous period of clinical seizure-free days per period as reported in a clinical seizure diary

  5. Time to pre-randomization clinical seizure count

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

    Duration, in days, between the beginning of the open-label treatment period and the nth clinical seizure, where n is the number of clinical seizures per 28-day period during the prospective pre-treatment baseline period, as reported in a clinical seizure diary

  6. RNS long episode 30%, 50%, 75% or with 100% responder proportions

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

    Proportion of participants with at least 30%, 50%, 75%, and 100% reduction in long episodes per 28-day period as recorded by the RNS® System

  7. Percent change in RNS long episode frequency

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

    Group median percent change in long episode frequency per 28-day period as recorded by the RNS® System

  8. Change in RNS long episode-free day frequency

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

    Group median change in long episode-free day frequency per 28-day period as recorded by the RNS® System

  9. Longest RNS long episode-free interval

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

    Duration, in days, of the longest continuous period of long episode-free days per period as recorded by the RNS® System

  10. Time to pre-randomization long episode count

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

    Duration, in days, between the beginning of the open-label treatment period and the mth long episode, where m is the number of long episodes per 28-day period during the pre-treatment baseline period, as recorded by the RNS® System

  11. Percent change in RNS estimated electrographic seizure frequency

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

    Group median percent change in estimated electrographic seizure frequency per 28-day period as recorded by the RNS® System

  12. Clinical Global Impression of Change (CGI-C) responder count and proportions

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

    Count and proportion of participants with any improvement (minimally improved, much improved, or very much improved) or clinically meaningful improvement (much improved or very much improved) as reported on the Clinical Global Impression of Change (CGI-C) scale

  13. Patient Global Impression of Change [PGI-C] responder count and proportions

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

    Count and proportion of participants with any improvement (minimally improved, much improved, or very much improved) or clinically meaningful improvement (much improved or very much improved) as reported on the Patient Global Impression of Change (PGI-C) scale

Study contacts

Contact information is provided by the study sponsor or research team.

Beth Bowers

CONTACT

[email protected]

(857) 323-9048

Daniela Moreno

CONTACT

[email protected]

(857) 323-9048

Sponsors and collaborators

Lead sponsor

Rapport Therapeutics Inc.

Industry

Registry information

Official study title

An Open-label, Long-term Study Evaluating RAP-219 in Adult Participants With Refractory Onset Seizures

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 21, 2025
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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