Acute Ischemic StrokePhase 2NCT06322394
BXOS110 Injection in the Treatment of Acute Ischaemic Stroke
A Phase 2 study testing high-dose BXOS110 and low-dose BXOS110 in people with Acute Ischemic Stroke, run by Biocells (Beijing) Biotech Co.,Ltd at 24 sites in China.
Trial summary
The purpose of this study was to evaluate the effectiveness of early administration of BXOS110 for injection in reducing overall disability in patients with acute ischaemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- high-dose BXOS110 and low-dose BXOS110
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 24 sitesChina
- Study dates
- 7 Feb 2024to Sep 2025
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age18~85 (including 18 and 85 years)，no gender limitation;
- Subjects diagnosed with acute ischaemic stroke according to the Chinese Guidelines for Clinical Management of Cerebrovascular Disease (2nd edition);
- 6 ≤ NIHSS score ≤ 20 before randomisation;
- Within 3h of stroke onset and expected to be able to start receiving the investigational product within 3 h of stroke onset (note: stroke onset time was calculated from the onset time of stroke symptoms; if stroke onset occurs during sleep, the stroke onset time should be taken as the latest normal appearance time);
- First stroke onset, or have a history of stroke but good prognosis (mRS score ≤1);
- Subjects who are able to understand and comply with the study procedures, and who agree to sign the study informed consent form in writing to indicate that they are willing to participate in the trial (the informed consent form can be signed by subjects or their legal representatives).
Who cannot join
- Imaging confirmed intracranial hemorrhagic disease (hemorrhagic stroke, epidural hematoma, intracranial hematoma, subarachnoid hemorrhage, ventricular hemorrhage, traumatic cerebral hemorrhage, etc.);
- Severe disturbance of consciousness: NIHSS 1a score ≥2 points;
- After aggressive antihypertensive therapy, hypertension still not under control: systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥110 mmHg;
- Severe hyperglycemia/hypoglycemia: blood glucose≥400 mg/dL (22.2 mmol/L), or ≤50 mg/dL (2.8 mmol/L);
- Heart rate < 50 beats /min or heart rate > 120 beats /min; Heart failure, unstable angina pectoris, acute myocardial infarction, and severe arrhythmias within the previous 6 months, as determined by the investigators to be severe heart disease, affected participants;
- Previously diagnosed severe hepatic and renal dysfunction and determined by the investigators as affect the subjects;
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- Patients who have been treated with neuroprotective agents after current stoke onset;
- Have a epilepsy history or have epilepsy symptoms after current stoke onset;
- Combined with other mental illnesses, resulting in inability or unwillingness to cooperate;
- Combined with claudication, osteoarthropathy, etc., resulting in limb movement dysfunction, which is determined by investigators to affect neurological function test;
- History of severe head trauma or stroke within 3 months before screening;
- History of severe food or drug allergy, or known allergy to the investigational drug and its excipients;
- Expected survival period is less than 3 months;
- Pregnant, planning pregnancy or breastfeeding patients;
- Suspected or confirmed history of alcohol or drug abuse;
- Participated in other drug or device clinical trial within the 3 months prior to screening or are participating in a other clinical trial;
- Other conditions, and the investigator assessed that participation in the study might increase the patient's risk or that participation in the study was deemed inappropriate by the investigator.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites, 24 recruiting
- Not yet recruiting
Anyang People's Hospital
Anyang, Henan
Jiangang Zhang, 86-13513722532, 709705699@qq.com
- Not yet recruiting
Beijing Tiantan Hospital , Capital Medical University
Beijing
Yongjun Wang, 86-13911172565, yongjunwang111@aliyun.com
- Recruiting
Beipiao Central Hospital
Chaoyang, Liaoning
Yutong Ma, 86-18642143339, myt3339@163.com
- Recruiting
Keshketengqi Hospital of Traditional Chinese Medicine and Mongolian Medicine
Chifeng, Neimenggu
Guozhi Lu, 86-13722169555, gz9555@sina.com
- Not yet recruiting
Daqing Oilfield General Hospital
Daqing, Heilongjiang
Dan Deng, 86-18245977799, 707604206@qq.com
- Not yet recruiting
Sinopharm Tongmei General Hospital
Datong, Shanxi
Junhai Wang, 86-13753265757, wjh1964@sohu.com
- Not yet recruiting
Ceneral Hospital of Mining Industry Group Fuxin
Fuxin, Liaoning
Yingjie Duan, 86-13470363261, 451142359@qq.com
- Not yet recruiting
Harrison International Peace Hospital
Hengshui, Hebei
Yan Wei, 86-18003188568, Hayuanwy@163.com
- Not yet recruiting
Liaocheng People's Hospital
Liaocheng, Shandong
Cunju Guo, 86-13346256168, cunjuguo@163.com
- Recruiting
Linfen Central Hospital
Linfen, Shanxi
Hongguo Dai, 86-15935767592, daihongguo3199@163.com
- Not yet recruiting
Linfen People's Hospital
Linfen, Shanxi
Junfang Hao, 86-13835360973, haojunfang2012@163.com
- Not yet recruiting
Linyi People's Hospital
Linyi, Shandong
Ziran Wang, 86-13954993801, wzr0806@163.com
- Not yet recruiting
MeiHekou Central Hospital
Meihekou, Jilin
Hong Yu, 86-13844564195, 2823974848@qq.com
- Not yet recruiting
Nanshi Hospital of Nanyang
Nanyang, Henan
Guang Wu, 86-13525687571, seizelinni@163.com
- Not yet recruiting
Nanyang Second General Hospital
Nanyang, Henan
Ming Wang, 86-15139096969, 15139096969@163.com
- Not yet recruiting
The First Affiliated Hospital of Nanyang Medicinal College
Nanyang, Henan
Tao Feng, 86-15638996063, 631740898@qq.com
- Not yet recruiting
Yuebei People's Hospital
Shaoguan, Guangdong
Junbin Chen, 86-13500205898, cjbcl0397@163.com
- Not yet recruiting
The Affiliated Hospital of Shenyang Medical College
Shenyang, Liaoning
Runhui Li, 86-18002477116, lirh710717@163.com
- Not yet recruiting
The First People's Hospital of Shenyang
Shenyang, Liaoning
Tie Sui, 86-13998352587, jakeyisui@icloud.com
- Not yet recruiting
The People's Hospital of Liaoning Province
Shenyang, Liaoning
Qiu He, 86-17702589222, qiuhe6392@sina.com
- Not yet recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
Xiaoyun Liu, 86-13191887318, a331083909@126.com
- Not yet recruiting
Tengzhou Central People's Hospital
Tengzhou, Shandong
Deyang Li, 86-13561190369, lideyang0632@163.com
- Not yet recruiting
Iron Coal General Hospital of Liaoning Health Industry Group
Tieling, Liaoning
Yu Wang, 86-13188417658, fffoo@sina.com
- Not yet recruiting
Xianyang Hospital of Yan'an University
Xianyang, Shaanxi
Wen Liu, 86-18740505535, 174461442@qq.com
About this study
Official title: A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of BXOS110 Injection in the Treatment of Acute Ischaemic Stroke Within 3 Hours of Onset
The purpose of this study was to evaluate the effectiveness of early administration of BXOS110 for injection in reducing overall disability in patients with acute ischaemic stroke.
Read the detailed description
This trial was conducted in a multicentre, randomised, double-blind, placebo-parallel controlled design, with a total of three groups of 100 subjects in each of the three planned groups, namely, the BXOS110 high-dose group (3.0 mg/kg, with a maximum dose of up to 300 mg), the BXOS110 low-dose group (2.0 mg/kg, with a maximum dose of up to 200 mg) and the placebo-control group, with the aim of exploring the efficacy and safety of BXOS110 at different doses of BXOS110. efficacy and safety of BXOS110.
The trial was divided into a screening/baseline period, a treatment period and a follow-up period. In the screening/baseline phase, patients signed an informed consent form within 3 hours of stroke onset to enter the trial, and after completing the screening and procedures related to the trial, subjects who met the enrolment requirements were randomly assigned to the BXOS110 high-dose group, the BXOS110 low-dose group, or a placebo-controlled group in a ratio of 1: 1: 1. During the treatment phase, subjects were randomly grouped into groups to start the intravenous treatment, and evaluations were carried out immediately after the administration of BXOS110. immediately after administration; during the Follow-up Period, subjects were evaluated for effectiveness and safety on Day 2, Day 3, Day 10, or at discharge (whichever occurred earlier), Day 30, and Day 90 after administration.
- Conditions
- Acute Ischemic Stroke
- Being tested
- high-dose BXOS110, low-dose BXOS110, 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.
high-dose BXOS110Drug
Also called BXOS110
3.0 mg/kg, maximum dose not exceeding 300 mg，Participants received one administration by intravenous infusion.
low-dose BXOS110Drug
Also called BXOS110
2.0 mg/kg, maximum dose not exceeding 200 mg，Participants received one administration by intravenous infusion.
PlaceboDrug
Does not contain any test drug active ingredients，Participants received one administration by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| BXOS110 high-dose group | Experimental | Name:BXOS110 Dosage form:injection Dosage:3.0 mg/kg, maximum dose not exceeding 300 mg Frequency:Frequency of injection is once Duration:10±1 min Receives: Drug: high-dose BXOS110 |
| BXOS110 low-dose group | Experimental | Name:BXOS110 Dosage form:injection Dosage:2.0 mg/kg, maximum dose not exceeding 300 mg Frequency:Frequency of injection is once Duration:10±1 min Receives: Drug: low-dose BXOS110 |
| Placebo control group | Placebo comparator | Dosage:0 mg/kg Frequency:Frequency of injection is once Duration:10±1 min Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with mRS score 0-2 on day 90
Modified Rankin scale The Rankin scale was devised in 1957 for assessment of stroke outcomes, and was modified in 1988 to improve its comprehensiveness.The modified version, or mRS, has since been commonly used to assess disability after a stroke.
The mRS attempts to measure functional independence, incorporating the WHO components of body function, activity, and participation. The scale is defined categorically with seven different grades: 0 indicates no symptoms, 5 indicates severe disability, and 6 indicates death.
A 1-point shift on this scale is often deemed clinically significant because of the large category sizes. Patients may use adaptive devices and still be considered independent, but the need for supervision or even minimum aid from another person is scored as dependent.
Measured: Day 90
Secondary outcomes (9)
Proportion of subjects with mRS score 0-1 on day 90
The modified version, or mRS, has since been commonly used to assess disability after a stroke.
The mRS attempts to measure functional independence, incorporating the WHO components of body function, activity, and participation. The scale is defined categorically with seven different grades: 0 indicates no symptoms, 5 indicates severe disability, and 6 indicates death.
A 1-point shift on this scale is often deemed clinically significant because of the large category sizes. Patients may use adaptive devices and still be considered independent, but the need for supervision or even minimum aid from another person is scored as dependent.
Measured: Day 90
Day 90 mRS Displacement Analysis
The modified version, or mRS, has since been commonly used to assess disability after a stroke.
The mRS attempts to measure functional independence, incorporating the WHO components of body function, activity, and participation. The scale is defined categorically with seven different grades: 0 indicates no symptoms, 5 indicates severe disability, and 6 indicates death.
A 1-point shift on this scale is often deemed clinically significant because of the large category sizes. Patients may use adaptive devices and still be considered independent, but the need for supervision or even minimum aid from another person is scored as dependent.
Measured: Day 90
Proportion of subjects with NIHSS scores ≤1 on day 10 (or at discharge)
The NIHSS is a 15-item impairment scale, which provides a quantitative measure of key components of a standard neurological examination.
The scale assesses level of consciousness, extraocular movements, visual fields, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria), and hemi-inattention (neglect).
Measured: Day 10
Proportion of subjects with a ≥4-point reduction in NIHSS score from baseline at day 10 (or at discharge)
The NIHSS is a 15-item impairment scale, which provides a quantitative measure of key components of a standard neurological examination.
The scale assesses level of consciousness, extraocular movements, visual fields, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria), and hemi-inattention (neglect).
Measured: D10
Proportion of subjects with ≥4 point increase in NIHSS score during hospitalisation
The NIHSS is a 15-item impairment scale, which provides a quantitative measure of key components of a standard neurological examination.
The scale assesses level of consciousness, extraocular movements, visual fields, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria), and hemi-inattention (neglect).
Measured: D1~ Day 10
Proportion of subjects with Barthel Index Scale (BI) scores ≥95 on day 90
The BI is a scale that measures ten basic aspects of activity related to self-care and mobility. The normal score is 100, and lower scores indicate greater dependency.
Measured: Day 90
Day 90 European Five Dimensional Health Scale (EQ-5D) Score
The EQ-5D is a generic HRQoL measurement with evidence of good reliability and validity in various disease populations, including stroke. The EQ-5D contains the self- reported health state profile of five dimensions (mobility, self-care, usual activity, pain/discomfort, and depression/ anxiety) and a visual analog scale (EQ-VAS) .
Measured: Day 90
Mortality due to stroke within 90 days
Mortality due to stroke within 90 days
Measured: Day 90
Change in infarct volume from baseline after 24 hours of dosing
Change in infarct volume from baseline after 24 hours of dosing
Measured: 24 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start7 Feb 2024
- Primary completionMar 2025 (estimated)
- Study completionSep 2025 (estimated)
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocells (Beijing) Biotech Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322394
- Sponsor's protocol ID
- BXOS110-Ⅱ-2023-12
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of BXOS110 Injection in the Treatment of Acute Ischaemic Stroke Within 3 Hours of Onset
- ClinicalTrials.gov ID
- NCT06322394
- Acronym / sponsor ID
- BXOS110-Ⅱ-2023-12
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Biocells (Beijing) Biotech Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 21 Mar 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.
The purpose of this study was to evaluate the effectiveness of early administration of BXOS110 for injection in reducing overall disability in patients with acute ischaemic stroke.
Detailed description
This trial was conducted in a multicentre, randomised, double-blind, placebo-parallel controlled design, with a total of three groups of 100 subjects in each of the three planned groups, namely, the BXOS110 high-dose group (3.0 mg/kg, with a maximum dose of up to 300 mg), the BXOS110 low-dose group (2.0 mg/kg, with a maximum dose of up to 200 mg) and the placebo-control group, with the aim of exploring the efficacy and safety of BXOS110 at different doses of BXOS110. efficacy and safety of BXOS110.
The trial was divided into a screening/baseline period, a treatment period and a follow-up period. In the screening/baseline phase, patients signed an informed consent form within 3 hours of stroke onset to enter the trial, and after completing the screening and procedures related to the trial, subjects who met the enrolment requirements were randomly assigned to the BXOS110 high-dose group, the BXOS110 low-dose group, or a placebo-controlled group in a ratio of 1: 1: 1. During the treatment phase, subjects were randomly grouped into groups to start the intravenous treatment, and evaluations were carried out immediately after the administration of BXOS110. immediately after administration; during the Follow-up Period, subjects were evaluated for effectiveness and safety on Day 2, Day 3, Day 10, or at discharge (whichever occurred earlier), Day 30, and Day 90 after administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BXOS110 high-dose group | Experimental | Drug: high-dose BXOS110Name:BXOS110 Dosage form:injection Dosage:3.0 mg/kg, maximum dose not exceeding 300 mg Frequency:Frequency of injection is once Duration:10±1 min |
| BXOS110 low-dose group | Experimental | Drug: low-dose BXOS110Name:BXOS110 Dosage form:injection Dosage:2.0 mg/kg, maximum dose not exceeding 300 mg Frequency:Frequency of injection is once Duration:10±1 min |
| Placebo control group | Placebo comparator | Drug: PlaceboDosage:0 mg/kg Frequency:Frequency of injection is once Duration:10±1 min |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age18~85 (including 18 and 85 years)，no gender limitation;
- Subjects diagnosed with acute ischaemic stroke according to the Chinese Guidelines for Clinical Management of Cerebrovascular Disease (2nd edition);
- 6 ≤ NIHSS score ≤ 20 before randomisation;
- Within 3h of stroke onset and expected to be able to start receiving the investigational product within 3 h of stroke onset (note: stroke onset time was calculated from the onset time of stroke symptoms; if stroke onset occurs during sleep, the stroke onset time should be taken as the latest normal appearance time);
- First stroke onset, or have a history of stroke but good prognosis (mRS score ≤1);
Key exclusion criteria (17 listed)
- Imaging confirmed intracranial hemorrhagic disease (hemorrhagic stroke, epidural hematoma, intracranial hematoma, subarachnoid hemorrhage, ventricular hemorrhage, traumatic cerebral hemorrhage, etc.);
- Severe disturbance of consciousness: NIHSS 1a score ≥2 points;
- After aggressive antihypertensive therapy, hypertension still not under control: systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥110 mmHg;
- Severe hyperglycemia/hypoglycemia: blood glucose≥400 mg/dL (22.2 mmol/L), or ≤50 mg/dL (2.8 mmol/L);
- Heart rate < 50 beats /min or heart rate > 120 beats /min; Heart failure, unstable angina pectoris, acute myocardial infarction, and severe arrhythmias within the previous 6 months, as determined by the investigators to be severe heart disease, affected participants;
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 |
|---|---|---|
| high-dose BXOS110Also: BXOS1103.0 mg/kg, maximum dose not exceeding 300 mg，Participants received one administration by intravenous infusion. | Drug | BXOS110 high-dose group |
| low-dose BXOS110Also: BXOS1102.0 mg/kg, maximum dose not exceeding 200 mg，Participants received one administration by intravenous infusion. | Drug | BXOS110 low-dose group |
| PlaceboDoes not contain any test drug active ingredients，Participants received one administration by intravenous infusion. | Drug | Placebo control group |
Primary outcome
Proportion of subjects with mRS score 0-2 on day 90
Time frame: Day 90
Modified Rankin scale The Rankin scale was devised in 1957 for assessment of stroke outcomes, and was modified in 1988 to improve its comprehensiveness.The modified version, or mRS, has since been commonly used to assess disability after a stroke. The mRS attempts to measure functional independence, incorporating the WHO components of body function, activity, and participation. The scale is defined categorically with seven different grades: 0 indicates no symptoms, 5 indicates severe disability, and 6 indicates death. A 1-point shift on this scale is often deemed clinically significant because of the large category sizes. Patients may use adaptive devices and still be considered independent, but the need for supervision or even minimum aid from another person is scored as dependent.
9 secondary outcomes
Proportion of subjects with mRS score 0-1 on day 90
Time frame: Day 90
Day 90 mRS Displacement Analysis
Time frame: Day 90
Proportion of subjects with NIHSS scores ≤1 on day 10 (or at discharge)
Time frame: Day 10
Proportion of subjects with a ≥4-point reduction in NIHSS score from baseline at day 10 (or at discharge)
Time frame: D10
Proportion of subjects with ≥4 point increase in NIHSS score during hospitalisation
Time frame: D1~ Day 10
Proportion of subjects with Barthel Index Scale (BI) scores ≥95 on day 90
Time frame: Day 90
Day 90 European Five Dimensional Health Scale (EQ-5D) Score
Time frame: Day 90
Mortality due to stroke within 90 days
Time frame: Day 90
Change in infarct volume from baseline after 24 hours of dosing
Time frame: 24 hours after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing high-dose BXOS110 and low-dose BXOS110 in people with Acute Ischemic Stroke, run by Biocells (Beijing) Biotech Co.,Ltd at 24 sites 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 17 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongjun Wang (86-13911172565, yongjunwang111@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with mRS score 0-2 on day 90 (time frame: Day 90). 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 21 Mar 2024.