Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT05020535
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2021-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D001929', 'term': 'Brain Edema'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007249', 'term': 'Inflammation'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C573580', 'term': 'TT-301'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants, study staff, analytic staff (to patient identifiers), sponsor staff (only to treatment allocation, unblinded to enable handling and review of data and drug accountability prior to database lock)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel 1:1'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2021-08-19', 'studyFirstSubmitQcDate': '2021-08-19', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in the proportion of all cause-morality between arms', 'timeFrame': '7 days post-randomization', 'description': 'Assess the safety and tolerability of MW189 for patients as determined by the rate of death during the treatment period.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intracerebral hemorrhage', 'MW01-6-189WH', 'MW189', 'Radiographic perihematomal edema', 'Neuroinflammation', 'Cerebral edema'], 'conditions': ['Intracerebral Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '41040632', 'type': 'DERIVED', 'citation': 'Sorensen G, Remillard W, Schlechter M, Kampp M, Whisler Brady C, Kildahl K, Mould A, Ziai W, Lane K, Van Eldik LJ, Distasio A, Lu J, Sansing LH, Hanley DF, Magid-Bernstein J. Operationalizing a complex acute clinical trial: Lessons from the BEACH study. J Clin Transl Sci. 2025 Sep 12;9(1):e215. doi: 10.1017/cts.2025.10152. eCollection 2025.'}, {'pmid': '40236420', 'type': 'DERIVED', 'citation': 'Sorensen G, Remillard W, Schlechter M, Kampp M, Sansing LH, Brady CW, Kidahl K, Ziai W, Van Eldik L, Distasio A, Lu J, Magid-Bernstein J, Hanley D. Operationalizing a complex acute clinical trial: Lessons from the BEACH study. medRxiv [Preprint]. 2025 Mar 31:2025.03.28.25324776. doi: 10.1101/2025.03.28.25324776.'}]}, 'descriptionModule': {'briefSummary': 'This first-in-patient phase 2a pilot study will assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH).', 'detailedDescription': 'This first-in-patient phase 2a pilot study will assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH).\n\nThis study will monitor exploratory radiographic and clinical endpoints, explore the use of biochemical biomarkers to demonstrate target engagement and biological response to a potential new therapy targeted to neuroinflammation and synaptic dysfunction mechanisms.\n\nMW189 is a novel small molecule drug candidate developed as a selective suppressor of disease-and injury-induced proinflammatory cytokine overproduction associated with destructive neuroinflammation/synaptic dysfunction cycles. In animal models of acute brain injuries such as ICH and Traumatic Brain Injury (TBI), MW189 attenuates neuroinflammation, reduces cerebral edema, and improves functional and cognitive performance. The investigators seek to establish if these targets are modified in humans with ICH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed diagnosis of spontaneous, non-traumatic ICH.\n* 10 mL ≤ ICH ≤ 60 mL (confirmed via diagnostic and stability CT scans utilizing volumetric assessment)\n* Participants receiving anticoagulants are eligible upon reversal and stability within 24hrs after onset of ICH symptoms\n* Age ≥ 18 years\n* Able to receive first dose of test article ≤ 24h after onset of ICH symptoms\n* NIHSS score ≥ 2 at randomization or Glasgow Coma Scale ≥ 5 at randomization\n* Controlled blood pressure (systolic BP \\< 180 mm Hg) at randomization.\n* Premorbid magnetic resonance spectroscopy (mRS) of 0-2\n* Has adequate venous access\n* No planned surgical intervention except EVD\n* Written informed consent from the patient or legally authorized representative (LAR)\n\nExclusion Criteria:\n\n* Unstable hematoma defined as \\> 6 mL increase as compared to previous CT volume taken at least 6 hours apart within 24 hrs after onset of ICH symptoms.\n* Anticipated neurosurgical evacuation by open surgery or minimally invasive surgery with or without Alteplase (EVD allowed).\n* Uncontrolled temp \\>38.5˚C at enrollment.\n* Signs of intracranial infection or emergence of a systemic infection\n* Is pregnant or lactating\n* Signs of liver and kidney chronic disease (i.e. creatinine \\>2, bilirubin \\> 3, receiving dialysis)\n* Non-reversible bleeding diathesis\n* Used any chronic immunosuppressants or chronic anti-inflammatory drugs (excluding low-dose aspirin), by any route of administration within the past 7 days.\n* Anticipated withdrawal of life-sustaining therapies within the first week after admission.\n* In the opinion of the investigator, patient has any contraindication to the planned study assessments.\n* In the opinion of the investigator, patient has a condition that could interfere with the proposed treatment or unacceptably increase the individual's risk by participating in the study.\n* Concomitant enrollment in another acute interventional study"}, 'identificationModule': {'nctId': 'NCT05020535', 'acronym': 'BEACH', 'briefTitle': 'Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) Phase 2a Trial', 'orgStudyIdInfo': {'id': 'IRB00295926'}, 'secondaryIdInfos': [{'id': '1R01AG069930-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01AG069930-01', 'type': 'NIH'}, {'id': 'R01AG069930', 'link': 'https://reporter.nih.gov/quickSearch/R01AG069930', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'MW189 (0.25 mg/kg) is administered within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)', 'interventionNames': ['Drug: MW189']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Administration of saline within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)', 'interventionNames': ['Other: Saline']}], 'interventions': [{'name': 'MW189', 'type': 'DRUG', 'description': 'MW189 (0.25 mg/kg) is administered within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)', 'armGroupLabels': ['Experimental']}, {'name': 'Saline', 'type': 'OTHER', 'description': 'Administration of saline within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Liptrap, MD', 'role': 'CONTACT', 'email': 'elizabethle@uabmc.edu', 'phone': '240-687-5928'}, {'name': 'Elizabeth Liptrap, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alabama Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chitra Venkatasubramanian, MD', 'role': 'CONTACT', 'email': 'chitrav@stanford.edu', 'phone': '650-723-4448'}, {'name': 'Chitra Venkatasubramanian, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Magid-Berntein', 'role': 'CONTACT', 'email': 'jessica.magid-bernstein@yale.edu', 'phone': '203-737-1057'}, {'name': 'Jessica Magid-Berntein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '34994', 'city': 'Stuart', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marc Babi, MD', 'role': 'CONTACT', 'email': 'BabiM@CCF.org', 'phone': '772-332-8073'}, {'name': 'Marc Babi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cleveland Clinic Florida', 'geoPoint': {'lat': 27.19755, 'lon': -80.25283}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kevin Hatton, MD', 'role': 'CONTACT', 'email': 'kevin.hatton@uky.edu', 'phone': '859-218-0115'}, {'name': 'Kevin Hatton, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Wendy Ziai, MD', 'role': 'CONTACT', 'email': 'weziai@jhmi.edu', 'phone': '410-292-6046'}, {'name': 'Daniel F Hanley, Jr', 'role': 'CONTACT', 'email': 'dhanley@jhmi.edu', 'phone': '410-614-6996'}, {'name': 'Wendy Ziai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrew Carlson, MD', 'role': 'CONTACT', 'email': 'AndrewCarlson@salud.unm.edu', 'phone': '505-272-9494'}, {'name': 'Andrew Carlson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11220', 'city': 'Brooklyn', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aaron Lord, MD', 'role': 'CONTACT', 'email': 'Aaron.Lord@nyulangone.org', 'phone': '718-630-8218'}, {'name': 'Aaron Lord, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New York University Grossman School of Medicine', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mario Zuccarello, MD', 'role': 'CONTACT', 'email': 'Mario.Zuccarello@uc.edu', 'phone': '513-558-3556'}, {'name': 'Mario Zuccarello, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tiffany Chang, MD', 'role': 'CONTACT', 'email': 'Tiffany.R.Chang@uth.tmc.edu', 'phone': '713-500-6128'}, {'name': 'Tiffany Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Justin Mascitelli, MD', 'role': 'CONTACT', 'email': 'mascitelli@uthscsa.edu'}, {'name': 'Justin Mascitelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Daniel Hanley', 'role': 'CONTACT', 'email': 'dhanley@jhmi.edu', 'phone': '(410) 361-7999'}, {'name': 'Cailin Brady', 'role': 'CONTACT', 'email': 'whisle1@jh.edu', 'phone': '(443) 927-3970'}], 'overallOfficials': [{'name': 'Linda Van Eldik', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Kentucky', 'class': 'OTHER'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}