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Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 28, 2025 (before its estimated August 10, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. 2 versions Re-verified since Feb 9, 2024, no change to tracked fieldsv5-v6
  2. Trial status: Not Yet Recruiting to Recruitingv4 Show 7 more changesShow less
    • Enrollment target: 66 to 25
    • Primary completion date: Aug 10, 2024 to Aug 10, 2026
    • Start date changed from estimate of Jan 10, 2023 to Jan 17, 2024
    • Study completion date: Nov 10, 2024 to Nov 10, 2026
    • Interventions: mirabegron (Drug), usual care (Other) to Standard treatment (Other), Standard treatment+mirabegron (Drug)
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: 5 to 6
  3. Start date: Aug 10, 2022 to Jan 10, 2023v3
  4. Start date: May 10, 2022 to Aug 10, 2022
    • Study description shortened, about 1 word
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Intracerebral hemorrhage (ICH) accounts for 10-15% of all strokes without effective pharmacological treatment. Inflammation following ICH contributes to barrier disruption and peri-hematoma edema, leading to deterioration of neurological function. Preclinical evidence suggests that bone marrow hematopoietic stem and progenitor cells (HSPCs) are swiftly activated after ICH. Thereafter, these HSPCs produce an increased output of anti-inflammatory monocytes as an endogenous protective mechanism. Stimulation of β3 adrenergic receptor using selective agonists promotes the production of anti-inflammatory monocytes in bone marrow, and thereby reduces neuroinflammation, brain edema and neurological deficits. This study is to assess the safety and efficacy of a β3 adrenergic receptor agonist Mirabegron as a potential treatment option in ICH patients.
Trial Details
NCT Number NCT05369351
Lead Sponsor Tianjin Medical University General Hospital
Conditions
(from sponsor)		 Intracerebral Haemorrhage
Related terms Cerebral Hemorrhage
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov