drugset / Trial / NCT05020535
Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)
Phase 2
Active not recruiting
120 enrolled
Johns Hopkins University
National Institute on Aging (NIA) · collabUniversity of Kentucky · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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).
Timeline
- Start
- 2022-10-10
- Primary completion
- 2026-11-30
- Completion
- 2027-10-01
Publications
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TT301 | Small molecule | 0.25 mg/kg | — |