RAP-219 for Bipolar Disorder

Recruiting at 21 trial locations

Overseen By Dawn F Fenton

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rapport Therapeutics Inc.

Disqualifiers: Schizophrenia, Schizoaffective, Substance use, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

224 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, RAP-219, to determine its safety and effectiveness for individuals with bipolar I disorder currently experiencing mania. Mania can involve feeling extremely energetic, overly happy, or irritable. Participants will receive either RAP-219 or a placebo (a pill resembling the real drug but without active ingredients) to compare results. This trial may suit those who have experienced at least one manic episode in the past five years requiring treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that RAP-219 was generally well tolerated in earlier studies. Patients who took RAP-219 for other conditions, such as certain types of seizures, experienced good safety outcomes. No major safety issues were reported, and patients handled the treatment well. This suggests that RAP-219 might be safe for individuals with bipolar I disorder, but researchers continue to study its safety in this specific group. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

RAP-219 is unique because it potentially offers a new approach for treating bipolar disorder. Most current treatments, like lithium and mood stabilizers, work by balancing neurotransmitters. However, RAP-219 is designed to target different pathways in the brain, which might lead to improved mood regulation with potentially fewer side effects. Researchers are excited because this could mean a more effective treatment option with a faster onset of action for those who struggle with the limitations of existing therapies.

What evidence suggests that RAP-219 might be an effective treatment for bipolar disorder?

Research has shown that RAP-219, which participants in this trial may receive, may help treat bipolar I disorder, particularly during manic episodes. Earlier studies found that patients using RAP-219 experienced noticeable improvements in their symptoms. These studies met their main goals with strong evidence, indicating the results are likely not due to chance. RAP-219 was also generally well tolerated by patients, suggesting it is safe to use. These findings indicate that RAP-219 could effectively manage mania linked to bipolar I disorder. ^{1 2 6 7 8}

Who Is on the Research Team?

Edwin A Gomez, MD

Principal Investigator

CenExel Research Centers of America

Are You a Good Fit for This Trial?

Adults with bipolar I disorder, who have had at least one manic episode in the past five years, can join this study. People with schizophrenia, schizoaffective disorder, major depression, severe substance or alcohol use disorders, certain personality disorders, or those who rapidly cycle between mood episodes are not eligible.

Inclusion Criteria

I have been diagnosed with bipolar I disorder, with or without additional symptoms.

I had a manic episode needing treatment within the last 5 years.

Exclusion Criteria

History of schizophrenia, schizoaffective disorder, major depressive disorder, moderate or severe substance or alcohol use disorder, as assessed by the SCID-5-CT

History of delirium, dementia, amnestic, or other cognitive disorders, borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorders, by medical history and/or Investigator opinion. Note: Any other current diagnoses must be discussed with the Medical Monitor.

Rapid cycler, defined as experiencing ≥4 distinct mood episodes (ie, manic or depressive) each meeting full DSM-5 criteria in the previous 12 months, and each separated by ≥2 months of full or partial remission, or a switch to an episode of the opposite polarity, as assessed by the SCID-5-CT.

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 for the acute treatment of manic episodes associated with bipolar I disorder

3 weeks

Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RAP-219

Trial Overview The trial is testing RAP-219 to see if it's safe and effective for treating mania in bipolar I disorder. Participants will either receive RAP-219 or a placebo (a treatment with no active drug) to compare outcomes.

How Is the Trial Designed?

Group I: Active Arm Experimental Treatment 1 Intervention

Treatment with RAP-219

Group II: 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-announces-positive-topline-results-phase-2a-clinical

Rapport Announces Positive Topline Results from Phase ... Trial met primary long episode endpoints with high statistical significance, and RAP-219 was generally well tolerated Patients achieved ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07046494?cond=Bipolar%20I%20Disorder&rank=2

Study Evaluating the Efficacy and Safety of RAP-219 in ... This is a Phase 2, proof-of-concept, multi-center, randomized, double blind, placebo-controlled study designed to evaluate the efficacy, safety and tolerability ...

3. biopharmadive.com biopharmadive.com/news/rapport-seizure-phase-2-study-results-stock-double/759486/

Rapport shares double on better-than-expected seizure ... Results from an open-label Phase 2 study showed treatment with Rapport's drug reduced a kind of seizure in people whose condition was ...

4. finance.yahoo.com finance.yahoo.com/news/rapport-announces-positive-topline-results-100000227.html

Rapport Announces Positive Topline Results from Phase ... Trial met primary long episode endpoints with high statistical significance, and RAP-219 was generally well toleratedPatients achieved 77.8% ...

5. investors.rapportrx.com investors.rapportrx.com/news-releases/news-release-details/rapport-therapeutics-announces-new-phase-1-data-further

Rapport Therapeutics Announces New Phase 1 Data ... Data from the trials demonstrated that RAP-219 achieved target receptor occupancy (RO) associated with maximal efficacy in prior preclinical ...

6. sec.gov sec.gov/Archives/edgar/data/2012593/000095017025104557/rapp-ex99_1.htm

EX-99.1 The Phase 2a trial of RAP-219 in drug-resistant focal onset seizures is fully enrolled and on track, with topline results expected in September ...

7. firstwordpharma.com firstwordpharma.com/story/6517671

Rapport Therapeutics Reports Third Quarter 2025 ... Positive topline results announced from Phase 2a clinical trial of RAP-219 in patients with focal onset seizures; Phase 2 trial of RAP-219 ...

8. neurologylive.com neurologylive.com/view/fda-places-clinical-hold-epilepsy-medication-rap-219-diabetic-peripheral-neuropathic-pain

FDA Places Clinical Hold on Epilepsy Agent RAP-219 for ... RAP-219 is being evaluated in ongoing trials for focal epilepsy and bipolar disorder, with promising initial safety data. A second multiple ...