Stroke, IschemicPhase 2XY03-EANCT06755944
A Phase Ⅱb Study of XY03-EA Tablets in Acute Ischemic Stroke
A Phase 2 study testing XY03-EA 150 mg (per dose), XY03-EA 300 mg (Regimen A) and XY03-EA 300 mg (Regimen B) in people with Stroke, Ischemic, run by Shijiazhuang Yiling Pharmaceutical Co. Ltd at 1 site in China.
Trial summary
This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase Ⅱb/Ⅲ clinical study to evaluate the efficacy and safety of XY03-EA tablets, a novel oral neuroprotective agent, and explore the dose-response relationship in 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?
- XY03-EA 150 mg (per dose), XY03-EA 300 mg (Regimen A) and XY03-EA 300 mg (Regimen B)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2024to 25 Nov 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years, inclusive (including both 18 and 80 years);
- Patients diagnosed with acute ischemic stroke according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke (2023), classified as total or partial anterior circulation infarction by the Oxfordshire Community Stroke Project (OCSP) classification;
- National Institutes of Health Stroke Scale (NIHSS) score of 6 to 20 at randomization;
- Time from "last seen normal" to initiation of study drug treatment ≤ 48 hours. For wake-up stroke, or when the time of symptom onset cannot be accurately determined due to aphasia, impaired consciousness, or other reasons, the time at which the patient was last seen to be normal shall be used;
- Patients with a first onset, or a recurrent onset with good recovery from the previous episode (modified Rankin Scale [mRS] score ≤ 1 before the current episode);
- The patient must understand and comply with the study procedures, voluntarily consent to participate, or have consent provided by a legal guardian, and sign the informed consent form.
Who cannot join
- Subjects who meet any of the following criteria will be excluded:
- Hemorrhagic cerebrovascular disease confirmed by imaging: cerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage, symptomatic hemorrhagic transformation, etc.;
- Patients who have received or intend to receive vascular recanalization therapy (intravenous thrombolysis or endovascular intervention);
- Severe disturbance of consciousness: NIHSS item 1a (level of consciousness) score ≥ 2;
- Use of neuroprotective agents after the onset of the current episode, including edaravone, edaravone dexborneol, butylphthalide, piracetam, citicoline, urinary kallidinogenase, etc.;
- Renal insufficiency: serum creatinine > 1.5 times the upper limit of normal, or other known severe renal insufficiency diseases;
Show all 19Show fewer
- Abnormal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times the upper limit of normal, or other known liver diseases such as acute or chronic hepatitis, cirrhosis, etc.;
- Poor blood pressure control despite active treatment: systolic blood pressure ≥ 220 mmHg and/or diastolic blood pressure ≥ 120 mmHg; hypotension: systolic blood pressure ≤ 80 mmHg and/or diastolic blood pressure ≤ 40 mmHg;
- Severe hyperglycemia or hypoglycemia: blood glucose ≥ 400 mg/dL (22.2 mmol/L) or ≤ 50 mg/dL (2.8 mmol/L);
- Heart rate < 50 beats/min or > 120 beats/min; second- or third-degree atrioventricular block; heart failure (New York Heart Association [NYHA] Class III or IV), unstable angina, acute myocardial infarction, or severe arrhythmia within the previous 6 months;
- Dementia, severe Parkinson's disease, mental disorders, limb dysfunction caused by claudication, osteoarthropathy, or other diseases, and other diseases that may affect the assessment of efficacy;
- Patients with malignant tumors, severe diseases of the hematologic, digestive, or other systems, or diseases with a bleeding tendency (e.g., hemophilia);
- Expected survival ≤ 3 months;
- Patients with a history of severe food or drug allergy, or known allergy to butylphthalide or celery;
- Patients who are pregnant, lactating, or planning pregnancy;
- Those who met the criteria for heavy drinking within 3 months before screening, i.e., daily drinking ≥ 5 standard drinks (1 standard drink equals 120 mL [approximately 2.5 liang] of wine, 360 mL [1 can] of beer, or 45 mL [approximately 1 liang] of liquor);
- Patients with drug abuse or addiction (e.g., narcotics or illicit drugs) within the past year;
- Those who have taken any investigational drug, or participated in any drug or device clinical trial or other medical research activities within 3 months before screening, and who were judged by the investigator to be unsuitable for participation in this study;
- Any other circumstances that, in the investigator's judgment, may affect the subject's ability to provide informed consent or compliance with the study protocol, or that may affect the study outcomes or the subject's safety.
Trial locations and contacts
1 site in 1 country.
China1 site
Shijiazhuang Yiling Pharmaceutical Co., Ltd
Shijiazhuang, Hebei, 050035
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase Ⅱb/Ⅲ Clinical Study to Evaluate the Efficacy and Safety of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke
This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase Ⅱb/Ⅲ clinical study to evaluate the efficacy and safety of XY03-EA tablets, a novel oral neuroprotective agent, and explore the dose-response relationship in patients with acute ischemic stroke. In the Phase Ⅱb stage, 360 eligible subjects were enrolled and randomly assigned to four XY03-EA dose groups and one placebo group in a 1:1:1:1:1 ratio. The primary endpoint was the proportion of patients with a modified Rankin Scale (mRS) score ≤ 1 at Day 90 after the start of study treatment.
Read the detailed description
Study Background and Rationale Acute ischemic stroke (AIS) is a leading cause of death and long-term disability worldwide. Despite advances in reperfusion therapies, including intravenous thrombolysis and endovascular thrombectomy, a substantial proportion of patients still experience poor functional outcomes, highlighting an unmet need for effective neuroprotective strategies that can salvage ischemic brain tissue and improve neurological recovery.
XY03-EA is a novel oral neuroprotective agent developed for the treatment of AIS. Preclinical pharmacodynamic and pharmacological studies have demonstrated that XY03-EA exerts neuroprotective effects by promoting reactive oxygen species (ROS) clearance and modulating autophagy-related proteins and signaling pathways in neural cells. These mechanisms significantly improve neurological function impaired by cerebral ischemia, with low toxicity and high activity observed in non-clinical studies.
Study Design This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase Ⅱb/Ⅲ clinical study conducted to evaluate the efficacy and safety of XY03-EA tablets in the treatment of acute ischemic stroke and to explore the dose-response relationship. The study was designed as a seamless Phase Ⅱb/Ⅲ trial; the Phase Ⅱb stage served as a dose-exploration phase to provide data support for the subsequent Phase Ⅲ stage.
Eligible patients were aged 18 to 80 years, diagnosed with acute ischemic stroke according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke (2023), classified as total or partial anterior circulation infarction by the Oxfordshire Community Stroke Project (OCSP) classification, with a National Institutes of Health Stroke Scale (NIHSS) score of 6 to 20, and enrolled within 48 hours from the time they were last seen normal.
In the Phase Ⅱb stage, 360 eligible subjects were enrolled and randomly assigned in a 1:1:1:1:1 ratio to four XY03-EA dose groups or one placebo group. Study treatment was administered for up to 90 days, with follow-up assessments conducted at scheduled time points.
Endpoints The primary efficacy endpoint was the proportion of patients with a modified Rankin Scale (mRS) score ≤ 1 at Day 90 after the start of study treatment. Secondary efficacy endpoints included the proportion of patients with mRS ≤ 2 at Day 14 (discharge), Day 30, and Day 90; the proportion of patients with mRS ≤ 1 at Day 30; the change from baseline in NIHSS score at Day 14 (discharge), Day 30, and Day 90; the proportion of patients with NIHSS ≤ 1 or a decrease of ≥ 4 points from baseline at Day 30 and Day 90; the proportion of patients with a Barthel Index (BI) ≥ 95 at Day 90; the change from baseline in Mini-Mental State Examination (MMSE) score at Day 90; and the proportion of patients with new vascular events (ischemic stroke, hemorrhagic stroke, transient ischemic attack, myocardial infarction, or vascular death) within 90 days after treatment. Safety was assessed throughout the study by monitoring adverse events, laboratory tests, vital signs, and physical examinations.
- Conditions
- Stroke, Ischemic
- Being tested
- XY03-EA 150 mg (per dose), XY03-EA 300 mg (Regimen A), XY03-EA 300 mg (Regimen B), XY03-EA 450 mg (per dose), Matching 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.
XY03-EA 150 mg (per dose)Drug
XY03-EA tablets, 150 mg/tablet, 1 tablet orally, three times daily (Tid), for 90 days
XY03-EA 300 mg (Regimen A)Drug
XY03-EA tablets, 150 mg/tablet, 2 tablets orally, Tid, for 90 consecutive days
XY03-EA 300 mg (Regimen B)Drug
XY03-EA tablets, 150 mg/tablet, 2 tablets orally, Tid, from Day 1 to Day 14
XY03-EA 450 mg (per dose)Drug
XY03-EA tablets, 150 mg/tablet, 3 tablets orally, Tid, for 90 days
Matching PlaceboDrug
Matching placebo tablets, orally, Tid, for 90 days (or as specified per arm)
| Study group | Role | What they receive |
|---|---|---|
| XY03-EA Tablet (150mg group) | Experimental | XY03-EA 150 mg/tablet, 1 tablet + 2 placebo tablets, orally, three times daily (Tid), for 90 days Receives: Drug: XY03-EA 150 mg (per dose); Drug: Matching Placebo |
| XY03-EA Tablet (300mg A group) | Experimental | XY03-EA 150 mg/tablet, 2 tablets + 1 placebo tablet, orally, Tid, for 90 consecutive days Receives: Drug: XY03-EA 300 mg (Regimen A); Drug: Matching Placebo |
| XY03-EA Tablet (300mg B group) | Experimental | XY03-EA 150 mg/tablet, 2 tablets + 1 placebo tablet, orally, Tid, from Day 1 to Day 14; then 3 placebo tablets, orally, Tid, from Day 15 to Day 90 Receives: Drug: XY03-EA 300 mg (Regimen B); Drug: Matching Placebo |
| XY03-EA Tablet (450mg group) | Experimental | XY03-EA 150 mg/tablet, 3 tablets, orally, Tid, for 90 days Receives: Drug: XY03-EA 450 mg (per dose) |
| XY03-EA Placebo group | Placebo comparator | Matching placebo tablets, 3 tablets, orally, Tid, for 90 days Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with Modified Rankin Scale (mRS) score ≤ 1 point at 90 days after administration.
Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6
- Dead. The mRS scores between 3 to 6 points are considered to be poor functional outcome.
Measured: 90 days
Secondary outcomes (7)
The proportion of patients with Modified Rankin Scale (mRS) score ≤ 2 point at 14(discharge) , 30,90 days after administration.
The proportion of patients with Modified Rankin Scale (mRS) score ≤ 2 point at 14(discharge) , 30,90 days after administration.
Measured: 14(discharge) , 30,90 days
The proportion of patients with Modified Rankin Scale (mRS) score ≤ 1 point at the 30 days after administration
The proportion of patients with Modified Rankin Scale (mRS) score ≤ 1 point at 30 days after administration
Measured: 30 days
The change of NIHSS score from baseline at 14(discharge) , 30,90 days after administration
The change of NIHSS score from baseline at 14(discharge) , 30,90 days after administration
Measured: 14(discharge) , 30,90 days
The proportion of patients with NIHSS score ≤1 or decrease ≥4 at 30 and 90 days after administration;
The proportion of patients with NIHSS score ≤1 or decrease ≥4 at 30 and 90 days after administration;
Measured: 30and 90 days
The proportion of patients with a BI ≥95 points at 90 days after administration
The proportion of patients with a BI ≥95 points at 90 days after administration
Measured: 90 days
The change in MMSE score compared with baseline at 90 days after administration
The change in MMSE score compared with baseline at 90 days after administration; Mini-Mental State Examination (MMSE) Grading criteria: 1 point for every correct item and 0 points for error. The total score range is 0~30 points, and the cut-off value between normal and abnormal is related to education level; Illiterate (uneducated) ≤ 17 points, primary school (≤ 6 years of schooling) ≤ 20 points, and secondary school or above (> 6 years of schooling) ≤ 24 points. Below the cut-off value is cognitive deficit, above is normal.
Measured: 90 days
The proportion of patients with new vascular events (ischemic stroke / hemorrhagic stroke / transient ischemic attack [TIA] / myocardial infarction / vascular death) within 90 days after administration.
The proportion of patients with new vascular events (ischemic stroke / hemorrhagic stroke / transient ischemic attack [TIA] / myocardial infarction / vascular death) within 90 days after administration.
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 posted1 Jan 2025
- Study start15 Dec 2024
- Primary completion9 Jun 2025
- Study completion25 Nov 2025
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shijiazhuang Yiling Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755944
- Sponsor's protocol ID
- XY03AIS2002/3001
- Acronym
- XY03-EA
- Status last verified
- Sep 2026
- First submitted
- 8 Dec 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase Ⅱb/Ⅲ Clinical Study to Evaluate the Efficacy and Safety of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06755944
- Acronym / sponsor ID
- XY03-EA / XY03AIS2002/3001
- Conditions
- Stroke, Ischemic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Shijiazhuang Yiling Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 9 Jun 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 1 Jan 2025 (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.
This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase Ⅱb/Ⅲ clinical study to evaluate the efficacy and safety of XY03-EA tablets, a novel oral neuroprotective agent, and explore the dose-response relationship in patients with acute ischemic stroke. In the Phase Ⅱb stage, 360 eligible subjects were enrolled and randomly assigned to four XY03-EA dose groups and one placebo group in a 1:1:1:1:1 ratio. The primary endpoint was the proportion of patients with a modified Rankin Scale (mRS) score ≤ 1 at Day 90 after the start of study treatment.
Detailed description
Study Background and Rationale Acute ischemic stroke (AIS) is a leading cause of death and long-term disability worldwide. Despite advances in reperfusion therapies, including intravenous thrombolysis and endovascular thrombectomy, a substantial proportion of patients still experience poor functional outcomes, highlighting an unmet need for effective neuroprotective strategies that can salvage ischemic brain tissue and improve neurological recovery.
XY03-EA is a novel oral neuroprotective agent developed for the treatment of AIS. Preclinical pharmacodynamic and pharmacological studies have demonstrated that XY03-EA exerts neuroprotective effects by promoting reactive oxygen species (ROS) clearance and modulating autophagy-related proteins and signaling pathways in neural cells. These mechanisms significantly improve neurological function impaired by cerebral ischemia, with low toxicity and high activity observed in non-clinical studies.
Study Design This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase Ⅱb/Ⅲ clinical study conducted to evaluate the efficacy and safety of XY03-EA tablets in the treatment of acute ischemic stroke and to explore the dose-response relationship. The study was designed as a seamless Phase Ⅱb/Ⅲ trial; the Phase Ⅱb stage served as a dose-exploration phase to provide data support for the subsequent Phase Ⅲ stage.
Eligible patients were aged 18 to 80 years, diagnosed with acute ischemic stroke according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke (2023), classified as total or partial anterior circulation infarction by the Oxfordshire Community Stroke Project (OCSP) classification, with a National Institutes of Health Stroke Scale (NIHSS) score of 6 to 20, and enrolled within 48 hours from the time they were last seen normal.
In the Phase Ⅱb stage, 360 eligible subjects were enrolled and randomly assigned in a 1:1:1:1:1 ratio to four XY03-EA dose groups or one placebo group. Study treatment was administered for up to 90 days, with follow-up assessments conducted at scheduled time points.
Endpoints The primary efficacy endpoint was the proportion of patients with a modified Rankin Scale (mRS) score ≤ 1 at Day 90 after the start of study treatment. Secondary efficacy endpoints included the proportion of patients with mRS ≤ 2 at Day 14 (discharge), Day 30, and Day 90; the proportion of patients with mRS ≤ 1 at Day 30; the change from baseline in NIHSS score at Day 14 (discharge), Day 30, and Day 90; the proportion of patients with NIHSS ≤ 1 or a decrease of ≥ 4 points from baseline at Day 30 and Day 90; the proportion of patients with a Barthel Index (BI) ≥ 95 at Day 90; the change from baseline in Mini-Mental State Examination (MMSE) score at Day 90; and the proportion of patients with new vascular events (ischemic stroke, hemorrhagic stroke, transient ischemic attack, myocardial infarction, or vascular death) within 90 days after treatment. Safety was assessed throughout the study by monitoring adverse events, laboratory tests, vital signs, and physical examinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| XY03-EA Tablet (150mg group) | Experimental | Drug: XY03-EA 150 mg (per dose), Drug: Matching PlaceboXY03-EA 150 mg/tablet, 1 tablet + 2 placebo tablets, orally, three times daily (Tid), for 90 days |
| XY03-EA Tablet (300mg A group) | Experimental | Drug: XY03-EA 300 mg (Regimen A), Drug: Matching PlaceboXY03-EA 150 mg/tablet, 2 tablets + 1 placebo tablet, orally, Tid, for 90 consecutive days |
| XY03-EA Tablet (300mg B group) | Experimental | Drug: XY03-EA 300 mg (Regimen B), Drug: Matching PlaceboXY03-EA 150 mg/tablet, 2 tablets + 1 placebo tablet, orally, Tid, from Day 1 to Day 14; then 3 placebo tablets, orally, Tid, from Day 15 to Day 90 |
| XY03-EA Tablet (450mg group) | Experimental | Drug: XY03-EA 450 mg (per dose)XY03-EA 150 mg/tablet, 3 tablets, orally, Tid, for 90 days |
| XY03-EA Placebo group | Placebo comparator | Drug: Matching PlaceboMatching placebo tablets, 3 tablets, orally, Tid, for 90 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)
- Age 18 to 80 years, inclusive (including both 18 and 80 years);
- Patients diagnosed with acute ischemic stroke according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke (2023), classified as total or partial anterior circulation infarction by the Oxfordshire Community Stroke Project (OCSP) classification;
- National Institutes of Health Stroke Scale (NIHSS) score of 6 to 20 at randomization;
- Time from "last seen normal" to initiation of study drug treatment ≤ 48 hours. For wake-up stroke, or when the time of symptom onset cannot be accurately determined due to aphasia, impaired consciousness, or other reasons, the time at which the patient was last seen to be normal shall be used;
- Patients with a first onset, or a recurrent onset with good recovery from the previous episode (modified Rankin Scale [mRS] score ≤ 1 before the current episode);
Key exclusion criteria (19 listed)
- Hemorrhagic cerebrovascular disease confirmed by imaging: cerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage, symptomatic hemorrhagic transformation, etc.;
- Patients who have received or intend to receive vascular recanalization therapy (intravenous thrombolysis or endovascular intervention);
- Severe disturbance of consciousness: NIHSS item 1a (level of consciousness) score ≥ 2;
- Use of neuroprotective agents after the onset of the current episode, including edaravone, edaravone dexborneol, butylphthalide, piracetam, citicoline, urinary kallidinogenase, etc.;
- Renal insufficiency: serum creatinine > 1.5 times the upper limit of normal, or other known severe renal insufficiency diseases;
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 |
|---|---|---|
| XY03-EA 150 mg (per dose)XY03-EA tablets, 150 mg/tablet, 1 tablet orally, three times daily (Tid), for 90 days | Drug | XY03-EA Tablet (150mg group) |
| XY03-EA 300 mg (Regimen A)XY03-EA tablets, 150 mg/tablet, 2 tablets orally, Tid, for 90 consecutive days | Drug | XY03-EA Tablet (300mg A group) |
| XY03-EA 300 mg (Regimen B)XY03-EA tablets, 150 mg/tablet, 2 tablets orally, Tid, from Day 1 to Day 14 | Drug | XY03-EA Tablet (300mg B group) |
| XY03-EA 450 mg (per dose)XY03-EA tablets, 150 mg/tablet, 3 tablets orally, Tid, for 90 days | Drug | XY03-EA Tablet (450mg group) |
| Matching PlaceboMatching placebo tablets, orally, Tid, for 90 days (or as specified per arm) | Drug | XY03-EA Placebo group, XY03-EA Tablet (150mg group), XY03-EA Tablet (300mg A group), XY03-EA Tablet (300mg B group) |
Primary outcome
The proportion of patients with Modified Rankin Scale (mRS) score ≤ 1 point at 90 days after administration.
Time frame: 90 days
Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead. The mRS scores between 3 to 6 points are considered to be poor functional outcome.
7 secondary outcomes
The proportion of patients with Modified Rankin Scale (mRS) score ≤ 2 point at 14(discharge) , 30,90 days after administration.
Time frame: 14(discharge) , 30,90 days
The proportion of patients with Modified Rankin Scale (mRS) score ≤ 1 point at the 30 days after administration
Time frame: 30 days
The change of NIHSS score from baseline at 14(discharge) , 30,90 days after administration
Time frame: 14(discharge) , 30,90 days
The proportion of patients with NIHSS score ≤1 or decrease ≥4 at 30 and 90 days after administration;
Time frame: 30and 90 days
The proportion of patients with a BI ≥95 points at 90 days after administration
Time frame: 90 days
The change in MMSE score compared with baseline at 90 days after administration
Time frame: 90 days
The proportion of patients with new vascular events (ischemic stroke / hemorrhagic stroke / transient ischemic attack [TIA] / myocardial infarction / vascular death) within 90 days after administration.
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 9 Sep 2026.
- Individual participant dataSharing planned: No
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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 2 study testing XY03-EA 150 mg (per dose), XY03-EA 300 mg (Regimen A) and XY03-EA 300 mg (Regimen B) in people with Stroke, Ischemic, run by Shijiazhuang Yiling 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 6 inclusion and 19 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 9 Sep 2026. 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 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?
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?
The proportion of patients with Modified Rankin Scale (mRS) score ≤ 1 point at 90 days after administration. (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 9 Sep 2026.