GD-11 injection for treating acute ischemic stroke

Phase III Clinical Trial of GD-11 for Injection in the Treatment of Acute Ischemic Stroke

This study is testing if an injection called GD-11 can help people who have had an acute ischemic stroke feel better and recover more effectively within 90 days.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 980 (estimated)
• Ages: 18 Years to 81 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (other)
• Locations: 2 sites (Beijing, Beijing and 1 other locations)
• Trial ID: NCT06299579 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the efficacy and safety of GD-11 for injection in patients diagnosed with acute ischemic stroke within 48 hours of onset. The study employs a multicenter, randomized, double-blind, parallel, placebo-controlled design, where participants are assigned to receive either GD-11 or a placebo for 10 days. The primary outcome measures the proportion of subjects achieving a modified Rankin Scale (mRS) score of 1 or less at 90 days post-treatment. Participants will be monitored for safety and stroke-related scale scores at specified intervals during the follow-up phase.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a confirmed diagnosis of acute ischemic stroke and specific NIHSS scores.

Not a fit: Patients who do not meet the eligibility criteria, such as those with NIHSS scores outside the specified range or those diagnosed with conditions other than ischemic stroke, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from acute ischemic stroke.

How similar studies have performed: Previous studies have shown promise in similar approaches for treating acute ischemic stroke, but this specific intervention is being evaluated for the first time in this context.

Eligibility criteria

Inclusion Criteria:

Only those who meet all of the following items will be enrolled:

1. age ≥18 years and \<81 years, male or female;
2. National Institutes of Health Stroke Scale (NIHSS) score: 6 ≤ NIHSS ≤ 20, and the sum of item 5 Upper Extremity and item 6 Lower Extremity scores ≥ 2 after the onset of this event;
3. The onset of the disease is within 48 hours (including 48 hours);
4. Patients who are diagnosed with ischemic stroke according to the requirements of the latest guidelines such as "Diagnostic Points of Various Major Cerebrovascular Diseases in China 2019" or "Clinical Management Guidelines of Cerebrovascular Diseases in China (2nd edition)", and who have a good healing after the first onset or the last onset (mRS score ≤1 before this onset);
5. Obtaining informed consent approved by the Ethics Committee voluntarily signed by the patients or their legal representatives.

Exclusion Criteria:

Those who met one of the following items at screening will not be eligible for enrollment:

1. intracranial hemorrhagic disease as seen on cranial imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.; if blood seepage only, the suitability for enrollment may be based on the investigator's judgment;
2. severe impairment of consciousness: item score \>1 on the 1a level of consciousness of the NIHSS;
3. thrombolysis, thrombolysis or intervention has been applied or is planned to be applied after this episode;
4. transient ischemic attack (TIA);
5. the patient's blood pressure remains ≥ 220 mmHg systolic or ≥ 120 mmHg diastolic after control;
6. patients with a previous diagnosis of severe mental disorders as well as patients with dementia;
7. patients who have been diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc.; or ALT (Alanine amino Transferase) or AST (Aspartate amino Transferase) \> 2.0 x ULN (Upper Limit of Normal Value);
8. patients who have been diagnosed with severe active renal disease, renal insufficiency; or serum creatinine \> 1.5 × ULN;
9. after the onset of the disease, the drug with neuroprotective effect has been used in the marketing, such as commercially available edaravone, edaravone dextran edaravone/(+)-2-Decanol injection concentrated solution, nimodipine, gangliosides, cytidine diphosphate, piracetam, oxiracetam, butylphenyl peptide, human urinary kallidinogenase (Urinary Kallidinogenase), cinepazide, murine nerve growth factor, cerebral vivax (hydrolysate of cerebral proteins), calf's blood deprivation of protein injection, calf's blood deprivation of protein extract injection and so on.
10. previously diagnosed with concurrent malignant tumors and undergoing anti-tumor therapy; for subjects diagnosed with malignant tumors after enrollment, continued participation in the study may be based on the investigator's judgment and the subject's wishes;
11. previously diagnosed with a serious systemic disease with an expected survival of \<90 days;
12. the patient is pregnant, breastfeeding and the patient/patient's partner has the potential for pregnancy and plans to become pregnant during the trial period
13. patients with a previously known hypersensitivity to GD-11 for Injection and its excipients;
14. history of major surgery within 4 weeks prior to enrollment that in the investigator's assessment affects neurologic function scores or affects 90-day survival;
15. participation in another clinical study within 30 days prior to randomization or ongoing participation in another clinical study; Not considered by the investigator to be suitable for participation in this clinical study.

Where this trial is running

Beijing, Beijing and 1 other locations

• Beijing Tiantan Hospital Capital Medical University Beijing — Beijing, Beijing, China (NOT_YET_RECRUITING)
• Linfen Central Hospital — Shangxi, Linfen City, China (RECRUITING)

Study contacts

• Study coordinator: Yongjun Wang

Conditions: Acute Ischemic Stroke, Subjects within 48 hours