RAP-219 for Partial Seizures

(FOCUS 1 Trial)

Overseen By Rapport Medical

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Rapport Therapeutics Inc.

Must be taking: Antiseizure medications

Disqualifiers: Generalized epilepsy, Uncontrolled conditions, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

333 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug called RAP-219, a potential treatment for seizures, to determine if it can safely and effectively reduce the number of focal seizures in adults. Focal seizures begin in one area of the brain and can affect functions like movement or awareness. Researchers will sort participants into groups receiving either a high dose, a medium dose, or a placebo (a pill with no active drug). Suitable candidates are adults who have had focal epilepsy for at least two years and are already taking 1 to 3 antiseizure medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial allows participants to continue taking between 1 and 3 antiseizure medications as maintenance. You won't need to stop your current antiseizure medications, but you should not be taking more than three.

Is there any evidence suggesting that RAP-219 is likely to be safe for humans?

Research has shown that RAP-219 is generally safe for people. Previous studies found no serious unwanted effects, with headaches and dizziness being the most common mild side effects. Earlier research with healthy volunteers demonstrated that RAP-219 was safe and well-tolerated. These findings suggest it is safe for many people with focal seizures. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for seizures?

RAP-219 is unique because it offers a potentially new approach to treating partial seizures. While most current treatments, like levetiracetam and lamotrigine, focus on modifying electrical signals in the brain or altering neurotransmitter activity, RAP-219 might target these seizures with a novel mechanism or formulation. Researchers are excited about RAP-219 because it could provide an alternative for patients who don't respond well to existing medications, potentially offering a tailored treatment option with the convenience of oral administration.

What evidence suggests that RAP-219 might be an effective treatment for partial seizures?

Research has shown that RAP-219 greatly reduces the number of seizures in people with focal epilepsy. In earlier studies, RAP-219 led to a 77.8% drop in seizures compared to before treatment. Additionally, 24% of participants experienced no seizures during an eight-week period, and about 72% of patients saw at least a 50% decrease in their seizures. Overall, these results suggest that RAP-219 could effectively reduce focal seizures. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 75 who have had focal epilepsy for at least two years, are taking 1-3 daily seizure medications, and can keep accurate seizure records. Participants must have recent brain scans confirming their diagnosis.

Inclusion Criteria

I am between 18 and 75 years old.

2. BMI 18-45 kg/m2

I have had focal epilepsy for at least 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RAP-219 or placebo during the double-blind treatment period

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Open-label extension

Participants may opt into the RAP-219-FOS-901 long-term safety study

What Are the Treatments Tested in This Trial?

Interventions

• RAP-219

Trial Overview

The study tests RAP-219, a new drug, against a placebo to see if it safely reduces the number of focal seizures in adults with epilepsy. Participants are randomly assigned to receive either RAP-219 or placebo.

How Is the Trial Designed?

Group I: Active Arm- Medium Dose Experimental Treatment 1 Intervention

RAP-219 daily tablets administered orally

Group II: Active Arm- High Dose Experimental Treatment 1 Intervention

RAP-219 daily tablets administered orally

Group III: Placebo Placebo Group 1 Intervention

Inert comparator matching the active treatment

Who Is Running the Clinical Trial?

Rapport Therapeutics Inc.

Lead Sponsor

Trials

1

Recruited

20+

Citations

1.

investors.rapportrx.com

investors.rapportrx.com/news-releases/news-release-details/rapport-therapeutics-announces-new-data-and-post-hoc-analysis/

Release Details

Study participants achieved a 77.8% reduction in clinical seizures compared with baseline (p=0.01), with 24% achieving seizure freedom during ...

2.

checkrare.com

checkrare.com/8-week-follow-up-data-of-rap-219-for-the-treatment-of-focal-onset-seizures/

8-Week Follow-Up Data of RAP-219 for the Treatment ...

Clinical seizures also showed a median 77.8% reduction with 72% of patients achieving a reduction of at least 50% over the treatment period.

3.

aesnet.org

aesnet.org/abstractslisting/efficacy-and-tolerability-of-rap-219-a-potential-first-in-class-negative-allosteric-modulator-of-%CE%B38-transmembrane-ampa-receptor-associated-protein-impact-on-rns-long-episodes-and-focal-seizures

efficacy and tolerability of rap-219, a potential first-in-class ...

Recent analyses suggest a ≥30% reduction in long episodes (LEs) as measured by the responsive neurostimulator (RNS® System, NeuroPace) is ...

4.

pharmacytimes.com

pharmacytimes.com/view/aan-2026-long-half-life-and-long-acting-injectable-what-pharmacists-should-know-about-rap-219-s-dosing-advantages-for-focal-epilepsy

AAN 2026: Long Half-Life and Long-Acting Injectable ...

Rapport Therapeutics' RAP-219 achieved seizure freedom in 24% of patients with drug-resistant focal epilepsy over 8 weeks in a phase 2 trial.

5.

clinicaltrial.be

clinicaltrial.be/en/details/452843?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Study Evaluating the Safety and Efficacy of RAP-219 in Ad...

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.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07563881

Study Evaluating the Efficacy and Safety of RAP-219 in ...

This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures. This study is being ...

7.

aesnet.org

aesnet.org/abstractslisting/safety-tolerability-and-pharmacokinetics-of-rap-219-in-healthy-volunteers

safety, tolerability, and pharmacokinetics of rap-219 in healthy ...

Safety, tolerability, and pharmacokinetics (PK) of RAP-219 in healthy, adult subjects were evaluated using single and multiple ascending dose ( ...