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

NCT06742216 | Completed Phase 3

• 1 other identifier: QLGM1-AIS-301
• Study Type: interventional
• Target: 1,232
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke

Outcome Measures

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

  90 days

Secondary Outcomes (1)

• Proportion of modified Rankin Scale (mRS) 0-1

  90 days

Study Arms (2)

Monosialoganglioside

EXPERIMENTAL

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

Drug: Monosialoganglioside

Placebo

PLACEBO COMPARATOR

Placebo, for 12-14 days

Drug: Placebo

Interventions

Monosialoganglioside DRUG

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

Monosialoganglioside

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；
• ≤NIHSS score ≤ 20；
• Signed informed consent.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Nanjing Gulou Medical College Affiliated Hospital

Nanjing, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: November 3, 2020
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

CN (1)