Stroke, IschemicPhase 4NCT04952064
An Exploratory Study of Ganglioside GM1 in Acute Ischemic Stroke
A Phase 4 study testing Monosialoganglioside GM1 in people with Stroke, Ischemic, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Monosialoganglioside GM1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2021to 18 Jul 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age: 18-80 years old；
- 2. Patients with anterior circulation cerebral infarction;
- 3. first stroke onset or past stroke without obvious neurological deficit (mRS score≤1)；
- 4. Within 24 hours of onset；
- 5. 5 ≤NIHSS score ≤ 20；
- 6. Signed informed consent.
Who cannot join
- 1. Patients with hereditary abnormal glucose and lipid metabolism (gangliosidosis, such as Tay-Sachs disease and retinal degeneration);
- 2. Hemorrhagic stroke;
- 3. Disturbance of consciousness (NIHSS1a≥1)，or cerebral arteritis, brain tumor, brain trauma, intracranial infectious diseases;
- 4. Planed endovascular treatment;
- 5. Uncontrolled hypertension: systolic pressure ≥200 mmHg or diastolic pressure ≥110 mmHg;
- 6. Bleeding tendency (except for thrombolysis) or severe bleeding within 3 months;
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- 7. Patients with malignant tumor or serious diseases;
- 8. Along with epilepsy, arthritis and other disease, which have effect on neurological assessment;
- 9. History of autoimmune diseases, spinal trauma, various demyelinating diseases, including acute inflammatory demyelinating polyneuropathy (Guillain Barre syndrome);
- 10. Unable or unwilling to cooperate due to mental diseases;
- 11. 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；
- 12. Hypersensitivity to monosialoganglioside and excipients of test drug;
- 13. History of drug abuse；
- 14. Pregnant or lactating women, pregnant plan or unwilling to use effective contraception during the trial period;
- 15. Participating in other clinical trials within 3 months;
- 16. Other conditions which are unsuitable for this trial assessed by researcher.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ganglioside GM1 in Acute Ischemic Stroke: a Prospective, Randomized, Blinded Assessment of Endpoints, and Multicenter Exploratory Study
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.
- Conditions
- Stroke, Ischemic
- Being tested
- Monosialoganglioside GM1
- Keywords
- monosialoganglioside GM1, Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monosialoganglioside GM1Drug
Also called GM1
Monosialoganglioside GM1 diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days
| Study group | Role | What they receive |
|---|---|---|
| 200 mg group | Experimental | Monosialoganglioside GM1, 200 mg/day, for 12-14 days Receives: Drug: Monosialoganglioside GM1 |
| 400 mg group | Experimental | Monosialoganglioside GM1, 400 mg/day, for 12-14 days Receives: Drug: Monosialoganglioside GM1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (3)
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
Measured: 90 days
changes in National Institute of Health stroke scale
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome
Measured: 7 days and 14 days
changes in Barthel index (BI) scale
the minimum and maximum values of BI are 0 and 100, respectively; higher BI mean a good outcome
Measured: 30 days and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start28 Jul 2021
- Primary completion18 Jul 2022
- Study completion18 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
- Investigators
- Chen Huisheng, Doctor, Study chair, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952064
- Sponsor's protocol ID
- Y（2021）052
- Status last verified
- Sep 2022
- First submitted
- 30 Jun 2021
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ganglioside GM1 in Acute Ischemic Stroke: a Prospective, Randomized, Blinded Assessment of Endpoints, and Multicenter Exploratory Study
- ClinicalTrials.gov ID
- NCT04952064
- Acronym / sponsor ID
- Y（2021）052
- Conditions
- Stroke, Ischemic
- Keywords
- monosialoganglioside GM1, Ischemic Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Collaborators
- The Third Xiangya Hospital of Central South University
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 200 mg group | Experimental | Drug: Monosialoganglioside GM1Monosialoganglioside GM1, 200 mg/day, for 12-14 days |
| 400 mg group | Experimental | Drug: Monosialoganglioside GM1Monosialoganglioside GM1, 400 mg/day, for 12-14 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Age: 18-80 years old；
- 2. Patients with anterior circulation cerebral infarction;
- 3. first stroke onset or past stroke without obvious neurological deficit (mRS score≤1)；
- 4. Within 24 hours of onset；
- 5. 5 ≤NIHSS score ≤ 20；
Key exclusion criteria (16 listed)
- 1. Patients with hereditary abnormal glucose and lipid metabolism (gangliosidosis, such as Tay-Sachs disease and retinal degeneration);
- 2. Hemorrhagic stroke;
- 3. Disturbance of consciousness (NIHSS1a≥1)，or cerebral arteritis, brain tumor, brain trauma, intracranial infectious diseases;
- 4. Planed endovascular treatment;
- 5. Uncontrolled hypertension: systolic pressure ≥200 mmHg or diastolic pressure ≥110 mmHg;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monosialoganglioside GM1Also: GM1Monosialoganglioside GM1 diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days | Drug | 200 mg group, 400 mg group |
Primary outcome
Proportion of modified Rankin Scale (mRS) 0-2
Time frame: 90 days
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome
3 secondary outcomes
Proportion of modified Rankin Scale (mRS) 0-1
Time frame: 90 days
changes in National Institute of Health stroke scale
Time frame: 7 days and 14 days
changes in Barthel index (BI) scale
Time frame: 30 days and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Huisheng, Doctor study chair
General Hospital of Shenyang Military Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Monosialoganglioside GM1 in people with Stroke, Ischemic, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of modified Rankin Scale (mRS) 0-2 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.