A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction

Beijing Suncadia Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Brain Swelling, Large Hemispheric Infarction

Treatments: Drug: Placebo; Drug: HRS8179

Study type: Interventional

Funder types: Industry

Identifiers

NCT05690711

HRS8179-201

Details and patient eligibility

About

The primary objective is to explore if HRS8179 could improve midline shift at 72 hours (or at time of decompressive craniectomy or comfort measures only, if earlier) in participants with large hemispheric infarction. The secondary objective is to explore if HRS8179 could improve acute neurologic status, functional outcomes, treatment requirements and safety.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Fully understand and voluntarily participate in this research, and sign the informed consent form (the informed consent form can be signed voluntarily by the person or legal representative);
2. Aged 18~80, regardless of gender;
3. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory;
4. NIHSS ≥ 10 points at screening;
5. A large hemispheric infarction is defined as: lesion volume of 80 to 300 cm3 on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP).
6. The study drug initiated must be no later than 10 hours when stroke onset;

Exclusion criteria

1. The investigator judges that the subject may withdrawn the supportive treatment on the first day; The investigator believes that there is evidence indicating a concurrent infarction in the contralateral hemisphere sufficiently serious to affect functional outcome.3. There are clinical signs of brain hernia;
2. CT/MRI suggested that the anterior septal/pineal excursion was >2 mm due to brain edema;
3. CT/MRI indicates cerebral hemorrhage (excluding small ecchymosis/punctate hemorrhage);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

HRS8179

Experimental group

Treatment:

Drug: HRS8179

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo