Using Mirabegron to treat intracerebral hemorrhage

Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage

This study is testing if adding Mirabegron to standard treatment can help people with intracerebral hemorrhage recover better by reducing brain swelling and inflammation.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Medical University General Hospital (Academic / other)
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT05369351 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of Mirabegron, a β3 adrenergic receptor agonist, in patients suffering from intracerebral hemorrhage (ICH). The research aims to determine if Mirabegron can reduce neuroinflammation and brain edema, potentially improving neurological outcomes. Participants will receive standard treatment along with Mirabegron or standard treatment alone. The study focuses on patients with specific criteria, including a hematoma volume of 5-30 ml and a Glasgow Coma Scale score between 6 and 12.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years with a specific volume of hematoma and a Glasgow Coma Scale score between 6 and 12.

Not a fit: Patients with multifocal cerebral hemorrhage, brain stem hemorrhage, or those requiring emergency surgical interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new pharmacological option for improving outcomes in patients with intracerebral hemorrhage.

How similar studies have performed: While the approach of using Mirabegron in this context is novel, preclinical evidence suggests potential benefits in reducing neuroinflammation.

Eligibility criteria

Inclusion Criteria:

1. Male or female patients aged above 18 years old.
2. The volume of the hematoma is 5-30 ml (including the cerebral cortex; Putamen, thalamus, caudate nucleus and related deep tracts; Cerebellar hemorrhage), which determined by CT scan.
3. The onset of cerebral hemorrhage symptoms or the time from last normal to detection is not more than 72 hours.
4. Patients with Glasgow Coma Scale (GCS) score ≥6 and \< 12.
5. Before the onset of the disease, function was independent and mRS score\<1.
6. Able and willing to sign written informed consent and comply with the requirements of the research protocol.

Exclusion criteria:

1. Multifocal cerebral hemorrhage, brain stem hemorrhage, or ventricular hemorrhage.
2. Secondary cerebral hemorrhage caused by aneurysm, brain tumor, arteriovenous malformation, thrombocytopenia, coagulation disorder, traumatic brain injury, etc.
3. Patients who require hematoma removal surgery or other emergency surgical interventions (such as decompressive craniectomy), or who are critically ill and close to death.
4. Patients who interfere with drug use due to nausea or vomiting.
5. Combined with the following conditions that preclude participation in the study due to other systemic diseases: Severe hepatic or renal impairment, atrial fibrillation or tachycardia, pulmonary infection, severe urinary tract infection, severe urinary tract obstruction, medically uncontrolled hypertension (systolic blood pressure ≥180mmHg or diastolic blood pressure ≥110mmHg), pregnant and lactating women, and a history of malignant tumors within 5 years.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Handong Li

Conditions Intracerebral Haemorrhage