A Phase 3 interventional study of Monosialoganglioside and Placebo in Acute Ischemic Stroke, sponsored by Qilu Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
A multicenter, randomized, double-blind, parallel, placebo-controlled trial design is used to evaluate the efficacy and safety of GM1 injection in the treatment of patients with acute ischemic stroke.
It is estimated that 1706 patients will be enrolled and randomly assigned to the treatment group and the placebo control group in a 1:1 ratio. Normally, the duration of this study is approximately 90 days.
Treatment was continued for 12\~14 days, and follow-up was conducted until the 90th day from the first dose.
The trial is divided into three phases: screening/baseline phase, treatment phase, and follow-up phase.
Screening/baseline period: After the subjects sign the informed consent form, they enter the screening/baseline period for screening examination.
Treatment period: Qualified subjects are randomly divided into groups in a 1:1 ratio and receive continuous treatment for 12\~14 days (12\~14 times) with GM1 injection and placebo respectively. During the treatment period, relevant examinations and evaluations required by the protocol will be carried out.
Follow-up period: Subjects who have completed treatment will enter the follow-up period until the 90th day of treatment.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 1,232 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Monosialoganglioside GM1, 200 mg/day, for 12-14 days
Drug: Monosialoganglioside
Placebo, for 12-14 days
Drug: Placebo
Monosialoganglioside diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days
Placebo diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days
Proportion of modified Rankin Scale (mRS) 0-2
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome
Time frame: 90 days
Proportion of modified Rankin Scale (mRS) 0-1
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome
Time frame: 90 days
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Qilu Pharmaceutical Co., Ltd.