Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG069930-01 | U.S. NIH Grant/Contract | View source | |
| R01AG069930 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Kentucky | OTHER |
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
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).
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).
This 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.
MW189 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | 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) |
|
| Control | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MW189 | Drug | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the proportion of all cause-morality between arms | Assess the safety and tolerability of MW189 for patients as determined by the rate of death during the treatment period. | 7 days post-randomization |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Linda Van Eldik | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41040632 | Derived | 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. | |
| 40236420 | Derived | 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. |
Not provided
Not provided
Not provided
Parallel 1:1
Not provided
Not provided
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)
| Saline | Other | 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) |
|
| Palo Alto |
| California |
| 94304 |
| United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06511 | United States |
| Cleveland Clinic Florida | Stuart | Florida | 34994 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| New York University Grossman School of Medicine | Brooklyn | New York | 11220 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| University of Texas Houston | Houston | Texas | 77030 | United States |
| University of Texas San Antonio | San Antonio | Texas | 78229 | United States |
| 37919545 | Derived | Avadhani R, Ziai WC, Thompson RE, Mould WA, Lane K, Nanni A, Iacobelli M, Sharrock MF, Sansing LH, Van Eldik LJ, Hanley DF; BEACH trial consortium. Clinical Trial Protocol for BEACH: A Phase 2a Study of MW189 in Patients with Acute Nontraumatic Intracerebral Hemorrhage. Neurocrit Care. 2024 Apr;40(2):807-815. doi: 10.1007/s12028-023-01867-2. Epub 2023 Nov 2. |
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D000090862 | Neuroinflammatory Diseases |
| D001929 | Brain Edema |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007249 | Inflammation |
Not provided
Not provided
| ID | Term |
|---|---|
| C573580 | TT-301 |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided