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CompletedNCT06742216Updated Dec 19, 2024

Monosialoganglioside in Acute Ischemic Stroke: a Randomized, Blinded and Multicenter Confirmatory Study

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

From the registry’s dates

  • Registered 4 years 1 month after the study started (first participant enrolled Nov 2020, registered Dec 2024).
Phase
Phase 3
Study type
Interventional
Enrollment
1,232
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

03

In context

Stroke

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age: 18-80 years old;
  • Patients with anterior circulation cerebral infarction; first stroke onset or past stroke without obvious neurological deficit (mRS score≤1);
  • Within 24 hours of onset;
  • 7 ≤NIHSS score ≤ 20;
  • Signed informed consent.

Exclusion criteria

Exclusion Criteria:

  • Patients with hereditary abnormal glucose and lipid metabolism (gangliosidosis, such as Tay-Sachs disease and retinal degeneration);
  • Hemorrhagic stroke;
  • Disturbance of consciousness (NIHSS1a≥1),or cerebral arteritis, brain tumor, brain trauma, intracranial infectious diseases;
  • Planed endovascular treatment;
  • Uncontrolled hypertension: systolic pressure ≥200 mmHg or diastolic pressure ≥110 mmHg;
  • Bleeding tendency (except for thrombolysis) or severe bleeding within 3 months;
  • Patients with malignant tumor or serious diseases;
  • Along with epilepsy, arthritis and other disease, which have effect on neurological assessment;
  • History of autoimmune diseases, spinal trauma, various demyelinating diseases, including acute inflammatory demyelinating polyneuropathy (Guillain Barre syndrome);
  • Unable or unwilling to cooperate due to mental diseases;
  • Abnormal liver and renal function: ALT, AST > 2 times of the upper limit of normal value, or Cr > 1.5 times of the upper limit of normal value;
  • Hypersensitivity to monosialoganglioside and excipients of test drug;
  • History of drug abuse;
  • Pregnant or lactating women, pregnant plan or unwilling to use effective contraception during the trial period;
  • Participating in other clinical trials within 3 months;
  • Other conditions which are unsuitable for this trial assessed by researcher.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,232 participants (actual)

Study arms

  • Experimental
    Monosialoganglioside

    Monosialoganglioside GM1, 200 mg/day, for 12-14 days

    Drug: Monosialoganglioside

  • Placebo comparator
    Placebo

    Placebo, for 12-14 days

    Drug: Placebo

Interventions

  • DrugMonosialoganglioside

    Monosialoganglioside diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days

  • DrugPlacebo

    Placebo diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Nanjing Gulou Medical College Affiliated Hospital
    Nanjing, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06742216
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Dec 19, 2024
Start date
Nov 3, 2020
Primary completion
Aug 30, 2023
Completion
Aug 30, 2023
Last update
Dec 19, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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