Acute Ischemic StrokePhase 3NCT06742216
Monosialoganglioside in Acute Ischemic Stroke: a Randomized, Blinded and Multicenter Confirmatory Study
A Phase 3 study testing Monosialoganglioside in people with Acute Ischemic Stroke, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Monosialoganglioside
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,232 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2020to 30 Aug 2023
- Phase
- Phase 3
- 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
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of Monosialoganglioside in the Treatment of Acute Ischemic Stroke
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.
Read more
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
- Being tested
- Monosialoganglioside, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonosialogangliosideDrug
Monosialoganglioside diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days
PlaceboDrug
Placebo diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days
| Study group | Role | What they receive |
|---|---|---|
| Monosialoganglioside | Experimental | Monosialoganglioside GM1, 200 mg/day, for 12-14 days Receives: Drug: Monosialoganglioside |
| Placebo | Placebo comparator | Placebo, for 12-14 days Receives: Drug: Placebo |
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 (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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start3 Nov 2020
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742216
- Sponsor's protocol ID
- QLGM1-AIS-301
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of Monosialoganglioside in the Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06742216
- Acronym / sponsor ID
- QLGM1-AIS-301
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,232 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 19 Dec 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monosialoganglioside | Experimental | Drug: MonosialogangliosideMonosialoganglioside GM1, 200 mg/day, for 12-14 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, 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 (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
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 |
|---|---|---|
| MonosialogangliosideMonosialoganglioside diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days | Drug | Monosialoganglioside |
| PlaceboPlacebo diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days | Drug | Placebo |
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
1 secondary outcome
Proportion of modified Rankin Scale (mRS) 0-1
Time frame: 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 19 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Monosialoganglioside in people with Acute Ischemic Stroke, run by Qilu Pharmaceutical Co., Ltd. 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 5 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 19 Dec 2024. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 19 Dec 2024.