Evaluating HRS8179 for treating severe brain swelling after a major stroke

The Efficacy and Safety of Intravenous HRS8179 for the Prevention and Treatment of Severe Cerebral Edema Following Large Hemispheric Infarction: a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II/III Clinical Trial

This study is testing if an injection called HRS8179 can help people with severe brain swelling after a major stroke feel better and recover more effectively.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 725 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06732648 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of HRS8179 injection in preventing and treating severe cerebral edema that occurs following a large hemispheric infarction. Participants diagnosed with acute ischemic stroke in the middle cerebral artery territory and exhibiting significant neurological impairment will receive either the HRS8179 treatment or a blank preparation. The study will monitor outcomes related to brain swelling and overall patient recovery. The trial is designed to gather data that could inform future treatment protocols for severe stroke complications.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with acute ischemic stroke in the middle cerebral artery territory, with a significant NIHSS score and large hemispheric infarction.

Not a fit: Patients who are likely to withdraw supportive treatment or have concurrent serious infarctions in the opposite hemisphere may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from severe cerebral edema after a stroke.

How similar studies have performed: While similar approaches have been explored, the specific use of HRS8179 for this condition is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Fully understand and voluntarily participate in this trial, and sign the informed consent form (the informed consent form can be signed voluntarily by the participant or their legal representative);
2. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory;
3. National Institutes of Health Stroke Scale (NIHSS) ≥ 10 at screening;
4. A large hemispheric infarction defined as: lesion volume of 80 to 160 cm3 on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP).
5. The time from onset to treatment must be ≤ 10 hours; if the onset time is unknown, treatment must be initiated within 10 hours after the time last known normal.

Exclusion Criteria:

1. Theparticipant is likely to withdraw the supportive treatment on the first day;
2. There is evidence indicating a concurrent infarction in the contralateral hemisphere sufficiently serious to affect functional outcome.
3. There are clinical signs of brain herniation; CT/MRI indicates a midline shift of \>2 mm; CT/MRI indicates cerebral hemorrhage;

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yu Gao

Conditions Severe Cerebral Edema Following Large Hemispheric Infarction