NCT04952064

Brief Summary

The purpose of this study was to evaluate the efficacy and safety of higher doses of monosialoganglioside GM1 injection in the treatment of patients with acute ischemic stroke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

July 28, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

12 months

First QC Date

June 30, 2021

Last Update Submit

September 22, 2022

Conditions

Stroke, Ischemic

Keywords

monosialoganglioside GM1Ischemic 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 (3)

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

    90 days

  • changes in National Institute of Health stroke scale

    7 days and 14 days

  • changes in Barthel index (BI) scale

    30 days and 90 days

Other Outcomes (2)

  • changes in some serum biomarkers

    7 days and 14 days

  • The change of infarct volume

    3 days

Study Arms (2)

200 mg group

EXPERIMENTAL

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

Drug: Monosialoganglioside GM1

400 mg group

EXPERIMENTAL

Monosialoganglioside GM1, 400 mg/day, for 12-14 days

Drug: Monosialoganglioside GM1

Interventions

Monosialoganglioside GM1DRUG

Monosialoganglioside GM1 diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days

Also known as: GM1
200 mg group400 mg group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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；
  • \. 5 ≤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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of ShenYang Military Region

Shenyang, Liaoning, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Chen Huisheng, Doctor

    General Hospital of Shenyang Military Region

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2021

First Posted

July 7, 2021

Study Start

July 28, 2021

Primary Completion

July 18, 2022

Study Completion

July 18, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Locations

CN(1)