Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Rapport Therapeutics Inc.
Study ID
NCT07046494
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Bipolar 1 Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • RAP-219 — DRUG
    RAP-219 tablets administered orally, once daily for 21 days
  • Placebo — OTHER
    Matching placebo tablets administered orally, once daily for 21 days

Study Details

This is a clinical research study for an investigational drug called RAP-219 in participants with bipolar I disorder. This study is being conducted to determine if RAP-219 is safe and effective in participants experiencing mania associated with bipolar I disorder.

Key Dates

Start date
Jul 25, 2025
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Arm
    Treatment with RAP-219
  • Placebo Comparator: Placebo
    Inert comparator matching the active treatment

Primary Outcome Measure

Young Mania Rating Scale (YMRS) [ Time Frame: Baseline to End of Treatment at Week 3 ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
Pillar Clinical Research - Little RockLittle RockArkansas72204-
Woodland International Research GroupLittle RockArkansas72211-
Woodland Research NorthwestRogersArkansas72758
Robert Billingsley, MD
Robert Billingsley, MD (PRINCIPAL_INVESTIGATOR)
Inland Psychiatric Medical Group - ChinoChinoCalifornia91710-
Synergy Clinical Research Center - San DiegoLemon GroveCalifornia91945
Charmaine Semeniuk, MD
Charmaine Semeniuk (PRINCIPAL_INVESTIGATOR)
Collaborative Neuroscience Research - Los AlamitosLos AlamitosCalifornia90720
David P Walling, PhD
David P Walling, PhD (PRINCIPAL_INVESTIGATOR)
NRC Research Institute - OrangeOrangeCalifornia92868
Daniel Chueh, MD
Daniel Chueh, MD (PRINCIPAL_INVESTIGATOR)
CNRI - San Diego, LLCSan DiegoCalifornia92123-
NeuroBehavioral Hospitals of the Palm Beaches - SouthBoynton BeachFlorida33426
Mohammad Asim Nisar, MD
Mohammad Asim Nisar, MD (PRINCIPAL_INVESTIGATOR)
United Research InstituteHialeahFlorida33012
Patrick Pinchinat, MD
Patrick Pinchinat (PRINCIPAL_INVESTIGATOR)
CenExel - HollywoodHollywoodFlorida33024
Edwin Gomez, MD
Edwin Gomez, MD (PRINCIPAL_INVESTIGATOR)
Segal Trials - Miami Lakes Medical Research Early Phase, Inpatient & Outpatient SiteMiami LakesFlorida33016
Rishi Kakar, MD
Rishi Kakar, MD (PRINCIPAL_INVESTIGATOR)
Neuroscience Research Institute at AmbrosiaWest Palm BeachFlorida33407
Danesh Alam, MD
Danesh Alam, MD (PRINCIPAL_INVESTIGATOR)
CenExel - DecaturDecaturGeorgia30030
Kimball Johnson, MD
Kimball Johnson, MD (PRINCIPAL_INVESTIGATOR)
Pillar Clinical Research - ChicagoChicagoIllinois60641
Roueen Rafeyan, MD
Roueen Rafeyan, MD (PRINCIPAL_INVESTIGATOR)
CenExel - GaithersburgGaithersburgMaryland20877-
Arch Clinical TrialsSt LouisMissouri63125
Kulsoom Juniad, MD
Kulsoom Juniad, MD (PRINCIPAL_INVESTIGATOR)
Richmond Behavioral AssociatesStaten IslandNew York10314
Peter Weiden
Peter Weiden, MD (PRINCIPAL_INVESTIGATOR)
New Hope Clinical ResearchCharlotteNorth Carolina28211
Kurian Abraham, MD
Kurian Abraham (PRINCIPAL_INVESTIGATOR)
Community Clinical Research, Inc.AustinTexas78754
Samuel Collier, MD
Samuel Collier, MD (PRINCIPAL_INVESTIGATOR)
HD Research - Memorial Hermann VillageHoustonTexas77043-
Pillar Clinical Research - RichardsonRichardsonTexas75080-

Find similar trials in Little Rock, AR

By research site
Pillar Clinical Research - Little Rock· Little Rock, ARWoodland International Research Group· Little Rock, ARWoodland Research Northwest· Rogers, ARInland Psychiatric Medical Group - Chino· Chino, CASynergy Clinical Research Center - San Diego· Lemon Grove, CACollaborative Neuroscience Research - Los Alamitos· Los Alamitos, CA

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