Suspended

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Edaravone Dexborneol Sequential Therapy in the Treatment of Patients With Acute Ischemic Stroke

What is being tested

Edaravone Dexborneol Sequential Therapy

+ Placebo

Drug

Who is being recruted

From 18 to 80 Years

+2 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: December 2023

See protocol details

Summary

Principal SponsorSimcere Pharmaceutical Co., Ltd

Study Contactyi wang, Master

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 28, 2023

Actual date on which the first participant was enrolled.

This clinical trial aims to evaluate the effectiveness and safety of a treatment called Edaravone Dexborneol for people who have recently experienced an acute ischemic stroke, a condition where blood flow to part of the brain is blocked. The study targets individuals who have had a stroke within the last 48 hours and have certain levels of impairment, as measured by a stroke severity score. The goal is to see if this treatment can help improve their recovery and reduce long-term disability. This study is important as it could potentially offer a new treatment option for stroke patients, helping them regain more independence and quality of life. Participants in the study receive the treatment in two stages. Initially, they are given Edaravone Dexborneol through an intravenous injection twice a day for up to 10 days. This is followed by taking Edaravone Dexborneol in the form of sublingual tablets, placed under the tongue, for the remainder of the 14-day treatment period. The study measures results by looking at participants' levels of disability 90 days after treatment, using a scale that assesses their ability to perform daily activities. Safety is closely monitored by tracking any adverse effects and changes in health indicators during the study period. Participants in the placebo group receive a non-active version of the treatment to compare outcomes effectively.

Official TitleA Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Edaravone Dexborneol Sequential Therapy in the Treatment of Patients With Acute Ischemic Stroke

NCT06176781

Principal SponsorSimcere Pharmaceutical Co., Ltd

Study Contactyi wang, Master

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

880 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate

1. Aged from 18 to 80 years old, male or female; 2. Baseline National Institutes of Health Stroke Scale (NIHSS) score between 6 and 20, a sum scores of the fifth upper limb and the sixth lower limb ≥2 at admission; 3. AIS symptom onset within 48 hours, onset time defined as when the patient was last known to be well; 4. According to the "Diagnostic criteria of cerebrovascular diseases in China (version 2019)", patients were diagnosed with ischemic stroke, with their first onset or recovered well after the last onset (mRS score ≤ 1 point before this onset); 5. Informed consent from the patient or legally authorized representative.

1 exclusion criteria prevent from participating

1. Intracranial bleeding disorders which were confirmed by cranial computed tomography scan, including hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc; 2. Severe disturbance of consciousness: NIHSS category 1a for consciousness >1; 3. Transient ischemic attack (TIA); 4. Systolic blood pressure ≥ 220 mmHg or diastolic blood pressure ≥ 120 mmHg after blood pressure control; 5. Severe mental disorder and dementia; 6. Alanine aminotransferase or aspartate transaminase > 2.0 × upper limit of normal value (ULN) or with known liver disorder, such as acute hepatitis, chronic active hepatitis, hepatic cirrhosis, etc； 7. Known kidney disease, renal insufficiency, serum creatinine > 1.5 × ULN or creatinine clearance < 50mL/min； 8. Received neuroprotective agents after this onset, including commercially available edaravone, edaravone dexborneol injection，nimodipine, ganglioside, citicoline, piracetam, butylphthalide, urinary kallidinogenase, etc； 9. Received or planed Embolectomy or interventional therapy after this onset； 10. Concurrent malignant tumor or currently receive antitumor treatment； 11. Severe systemic disease and life expectancy < 90 days; 12. Allergies to edaravone, dexborneol, or the excipients; 13. Pregnant or lactating patients or patients who plan to become pregnant; 14. History of a major surgery within 4 weeks before enrollment; 15. Participated in other clinical trials within 30 days before randomization or currently involved in other clinical trials; 16. Investigators consider they are not suitable for this trial.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Edaravone Dexborneol concentrated solution for injections 37.5 mg BID administered intravenously for 5 - 10 days, and then followed by Edaravone Dexborneol Sublingual Tablets 30 mg BID administered sublingually for the last days, the total duration of treatment was 14 days

Group II

Placebo

Injection Simulants(Edaravone Dexborneol concentrated solution for injections) administered intravenously for 5 - 10 days, and then followed by Sublingual Tablet Simulants(Edaravone Dexborneol Sublingual Tablets) BID administered sublingually for the last days, the total duration of treatment was 14 days

Study Objectives

Primary Objectives

Study Centers

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SuspendedNo study centers