Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-26 @ 12:22 AM
Study NCT ID:
NCT07046494
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000087122', 'term': 'Mania'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a placebo-controlled trial of active drug versus placebo.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 224}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-05-30', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Young Mania Rating Scale (YMRS)', 'timeFrame': 'Baseline to End of Treatment at Week 3', 'description': "The YMRS is a clinician administered scale that consists of 11 items used to assess the severity of manic symptoms (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania."}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness Mania score', 'timeFrame': 'Baseline to end of Treatment at Week 3', 'description': 'The CGI-BP Severity of Illness Mania score is a clinician-rated scale used to assess the severity of manic symptoms, depression and overall illness severity in individuals with bipolar disorder. The mania score ranges from 1 (not ill) to 7 (very severely ill), with higher scores indicating greater severity of manic symptoms.'}, {'measure': 'Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Baseline to end of Study Period 8 Weeks after date of last dose', 'description': 'Incidence and severity of treatment-emergent adverse events (TEAEs).'}, {'measure': 'Heart Rate', 'timeFrame': 'Baseline to end of Study Period 8 Weeks after date of last dose', 'description': 'Change in Heart Rate (BPM)'}, {'measure': 'Respiratory Rate', 'timeFrame': 'Baseline to end of Study Period 8 Weeks after date of last dose', 'description': 'Change in Respiratory Rate (breaths per minute)'}, {'measure': 'Body Temperature', 'timeFrame': 'Baseline to end of Study Period 8 Weeks after date of last dose', 'description': 'Change in body temperature'}, {'measure': 'Blood Pressure', 'timeFrame': 'Baseline to end of Study Period 8 Weeks after date of last dose', 'description': 'Change in blood pressure (Hg mm)'}, {'measure': 'Laboratory Analytes', 'timeFrame': 'Baseline to end of Study Period 8 Weeks after date of last dose', 'description': 'Change in laboratory analytes (absolute value)'}, {'measure': 'Electrocardiogram (ECG) QTc interval', 'timeFrame': 'Baseline to end of Study Period 8 Weeks after date of last dose', 'description': 'Changes in electrocardiogram (ECGs); QTc prolongation'}, {'measure': 'Electrocardiogram (ECG) abnormal findings', 'timeFrame': 'Baseline to end of Study Period 8 Weeks after date of last dose', 'description': 'Shift table of normal to abnormal ECG findings'}, {'measure': 'Suicidality', 'timeFrame': 'Baseline to end of Study Period 8 Weeks after date of last dose', 'description': 'Incidence of suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bipolar', 'Mania', 'Acute', 'In-patient', 'Manic State', 'Manic Episode', 'Mixed Features', 'Episode with Mixed Features', 'Mixed Mania', 'Bipolar Episode'], 'conditions': ['Bipolar 1 Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This is a Phase 2, proof-of-concept, multi-center, randomized, double blind, placebo-controlled study designed to evaluate the efficacy, safety and tolerability of RAP-219 in adult participants experiencing mania associated with bipolar I disorder. This is a 3-week inpatient clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of bipolar I disorder, with or without psychotic symptoms, as confirmed by the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT). Episode may contain mixed features, as confirmed by Montgomery-Åsberg Depression Rating Scale (MADRS).\n* Had at least one prior documented manic episode (with or without psychotic symptoms) that required treatment, within 5 years prior to Visit 1\n\nExclusion Criteria:\n\n* History of any of the following diagnoses: a. schizophrenia; schizoaffective disorder; major depressive disorder; moderate or severe substance or alcohol use disorder; as assessed by the SCID-5-CT b. 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.\n* 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'}, 'identificationModule': {'nctId': 'NCT07046494', 'briefTitle': 'Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rapport Therapeutics Inc.'}, 'officialTitle': 'A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder', 'orgStudyIdInfo': {'id': 'RAP-219-BPM-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Arm', 'description': 'Treatment with RAP-219', 'interventionNames': ['Drug: RAP-219']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Inert comparator matching the active treatment', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'RAP-219', 'type': 'DRUG', 'description': 'RAP-219 tablets administered orally, once daily for 21 days', 'armGroupLabels': ['Active Arm']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Matching placebo tablets administered orally, once daily for 21 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72204', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leslie Smith, MD', 'role': 'CONTACT'}, {'name': 'Leslie Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pillar Clinical Research - Little Rock', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'George Konis, MD', 'role': 'CONTACT'}, {'name': 'George Konis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Woodland International Research Group', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert Billingsley, MD', 'role': 'CONTACT'}, {'name': 'Robert Billingsley, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Woodland Research Northwest', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '91710', 'city': 'Chino', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nandita Puchakayala, MD', 'role': 'CONTACT'}, {'name': 'Nandita Puchakayala, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Inland Psychiatric Medical Group - Chino', 'geoPoint': {'lat': 34.01223, 'lon': -117.68894}}, {'zip': '91945', 'city': 'Lemon Grove', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Charmaine Semeniuk, MD', 'role': 'CONTACT'}, {'name': 'Charmaine Semeniuk', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Synergy Clinical Research Center - San Diego', 'geoPoint': {'lat': 32.74255, 'lon': -117.03142}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Haig Goenjian, MD', 'role': 'CONTACT'}, {'name': 'Haig Goenjian', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Collaborative Neuroscience Research - Los Alamitos', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel Chueh, MD', 'role': 'CONTACT'}, {'name': 'Daniel Chueh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NRC Research Institute - Orange', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher Benbow, MD', 'role': 'CONTACT'}, {'name': 'Christopher Benbow, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CNRI - San Diego, LLC', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33426', 'city': 'Boynton Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mohammad Asim Nisar, MD', 'role': 'CONTACT'}, {'name': 'Mohammad Asim Nisar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NeuroBehavioral Hospitals of the Palm Beaches - South', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patrick Pinchinat, MD', 'role': 'CONTACT'}, {'name': 'Patrick Pinchinat', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'United Research Institute', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Edwin Gomez, MD', 'role': 'CONTACT'}, {'name': 'Edwin Gomez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CenExel - Hollywood', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33016', 'city': 'Miami Lakes', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rishi Kakar, MD', 'role': 'CONTACT'}, {'name': 'Rishi Kakar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Segal Trials - Miami Lakes Medical Research Early Phase, Inpatient & Outpatient Site', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Danesh Alam, MD', 'role': 'CONTACT'}, {'name': 'Danesh Alam, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Neuroscience Research Institute at Ambrosia', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kimball Johnson, MD', 'role': 'CONTACT'}, {'name': 'Kimball Johnson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CenExel - Decatur', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60641', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roueen Rafeyan, MD', 'role': 'CONTACT'}, {'name': 'Roueen Rafeyan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pillar Clinical Research - Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '20877', 'city': 'Gaithersburg', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elia Acevedo-Diaz, MD', 'role': 'CONTACT'}, {'name': 'Elia Acevedo-Diaz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CenExel - Gaithersburg', 'geoPoint': {'lat': 39.14344, 'lon': -77.20137}}, {'zip': '63125', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kulsoom Juniad, MD', 'role': 'CONTACT'}, {'name': 'Kulsoom Juniad, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arch Clinical Trials', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10314', 'city': 'Staten Island', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Peter Weiden', 'role': 'CONTACT'}, {'name': 'Peter Weiden, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Richmond Behavioral Associates', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '28211', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kurian Abraham, MD', 'role': 'CONTACT'}, {'name': 'Kurian Abraham', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New Hope Clinical Research', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '78754', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Samuel Collier, MD', 'role': 'CONTACT'}, {'name': 'Samuel Collier, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Community Clinical Research, Inc.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77043', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': "Dominick D'Aunno, MD", 'role': 'CONTACT'}, {'name': "Dominick D'Aunno, MD", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HD Research - Memorial Hermann Village', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75080', 'city': 'Richardson', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Scott Bartley, MD', 'role': 'CONTACT'}, {'name': 'Scott Bartley, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pillar Clinical Research - Richardson', 'geoPoint': {'lat': 32.94818, 'lon': -96.72972}}], 'centralContacts': [{'name': 'Dawn F Fenton', 'role': 'CONTACT', 'email': 'dfenton@rapportrx.com', 'phone': '(857) 323-9048'}], 'overallOfficials': [{'name': 'Edwin A Gomez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CenExel Research Centers of America'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rapport Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}