A Phase Ⅱb Study of XY03-EA Tablets in Acute Ischemic Stroke

NCT06755944 | Completed Phase 2

• 1 other identifier: XY03AIS2002/3001
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  14(discharge) , 30,90 days

• The proportion of patients with Modified Rankin Scale (mRS) score ≤ 1 point at the 30 days after administration

  30 days

• The change of NIHSS score from baseline at 14(discharge) , 30,90 days after administration

  14(discharge) , 30,90 days

• The proportion of patients with NIHSS score ≤1 or decrease ≥4 at 30 and 90 days after administration;

  30and 90 days

• The proportion of patients with a BI ≥95 points at 90 days after administration

  90 days

Study Arms (5)

XY03-EA Tablet (150mg group)

EXPERIMENTAL

XY03-EA 150 mg/tablet, 1 tablet + 2 placebo tablets, orally, three times daily (Tid), for 90 days

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

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

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

Drug: XY03-EA 450 mg (per dose)

XY03-EA Placebo group

PLACEBO COMPARATOR

Matching placebo tablets, 3 tablets, orally, Tid, for 90 days

Drug: Matching Placebo

Interventions

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 Tablet (150mg group)

XY03-EA 300 mg (Regimen A) DRUG

XY03-EA tablets, 150 mg/tablet, 2 tablets orally, Tid, for 90 consecutive days

XY03-EA Tablet (300mg A group)

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 Tablet (300mg B group)

XY03-EA 450 mg (per dose) DRUG

XY03-EA tablets, 150 mg/tablet, 3 tablets orally, Tid, for 90 days

XY03-EA Tablet (450mg group)

Matching Placebo DRUG

Matching placebo tablets, orally, Tid, for 90 days (or as specified per arm)

XY03-EA Placebo group; XY03-EA Tablet (150mg group); XY03-EA Tablet (300mg A group); XY03-EA Tablet (300mg B group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Shijiazhuang Yiling Pharmaceutical Co. Ltd: lead

Study Sites (1)

Shijiazhuang Yiling Pharmaceutical Co., Ltd

Shijiazhuang, Hebei, 050035, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Regimen B

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: January 1, 2025
• Study Start: December 15, 2024
• Primary Completion: June 9, 2025
• Study Completion: November 25, 2025
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)