Can a new pill help stroke patients regain independence?
NCT ID NCT06755944
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers are testing an experimental oral drug called XY03-EA in adults who have just had an acute ischemic stroke. The trial compares several doses of the drug with a placebo to see whether it improves recovery and reduces disability. About 360 participants receive treatment for up to 90 days, and researchers measure how well they function in daily activities.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- XY03-EA tablets, an experimental oral neuroprotective drug
- What this could lead to
- If XY03-EA works, it could become an easy-to-take pill that helps stroke patients recover more independence in their daily lives.
- What could go wrong
- This is a mid-stage trial, so even if the drug helps, larger studies will be needed. Many neuroprotective drugs that looked promising in earlier testing have failed to show benefit in people.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
360 people
The number who actually took part.
- Started
-
Dec 2024
- Finished
-
Nov 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
\*\*Inclusion Criteria:\*\* 1. Age 18 to 80 years, inclusive (including both 18 and 80 years); 2. 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; 3. National Institutes of Health Stroke Scale (NIHSS) score of 6 to 20 at randomization; 4. 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; 5. 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); 6. 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. \*\*Exclusion Criteria:\*\* Subjects who meet any of the following criteria will be excluded: 1. Hemorrhagic cerebrovascular disease confirmed by imaging: cerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage, symptomatic hemorrhagic transformation, etc.; 2. Patients who have received or intend to receive vascular recanalization therapy (intravenous thrombolysis or endovascular intervention); 3. Severe disturbance of consciousness: NIHSS item 1a (level of consciousness) score ≥ 2; 4. Use of neuroprotective agents after the onset of the current episode, including edaravone, edaravone dexborneol, butylphthalide, piracetam, citicoline, urinary kallidinogenase, etc.; 5. Renal insufficiency: serum creatinine \> 1.5 times the upper limit of normal, or other known severe renal insufficiency diseases; 6. 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.; 7. 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; 8. Severe hyperglycemia or hypoglycemia: blood glucose ≥ 400 mg/dL (22.2 mmol/L) or ≤ 50 mg/dL (2.8 mmol/L); 9. 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; 10. 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; 11. Patients with malignant tumors, severe diseases of the hematologic, digestive, or other systems, or diseases with a bleeding tendency (e.g., hemophilia); 12. Expected survival ≤ 3 months; 13. Patients with a history of severe food or drug allergy, or known allergy to butylphthalide or celery; 14. Patients who are pregnant, lactating, or planning pregnancy; 15. 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); 16. Patients with drug abuse or addiction (e.g., narcotics or illicit drugs) within the past year; 17. 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; 18. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Shijiazhuang Yiling Pharmaceutical Co., Ltd
Shijiazhuang, Hebei, 050035, China
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Other studies related to the condition(s) this trial covers.
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