Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke

NCT06645522 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: ED-AIS
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke.

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; Edaravone Dexborneol

Outcome Measures

Primary Outcomes (1)

• modified rankin scale (mRS) score ≤ 1

  The proportion of patients with mRS score of 1 or less on day 90 after randomization. Ranged from 0 to 6, a low value represents a better outcome.

  Day 90 after randomization

Secondary Outcomes (5)

• Serum ubiquitin C-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), S100β, neuron-specific enolase (NSE) levels

  Day 3 after randomization

• Serum ubiquitin C-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), S100β, neuron-specific enolase (NSE) levels

  Day 7 after randomization

• NIHSS score on day 7

  Day 7 after randomization

• mRS score ≤ 2

  Day 90 after randomization

• Distribution of mRS score

  Day 90 after randomization

Study Arms (2)

Edaravone dexborneol group

EXPERIMENTAL

Edaravone dexborneol injection 37.5mg every 12 hours for 7 days and a sublingual dose of edaravone dexborneol 36 mg twice a day for 21 days.

Drug: Edaravone dexborneol

Placebo group

PLACEBO COMPARATOR

Placebo injection every 12 hours for 7 days and a sublingual dose of placebo drug twice a day for 21 days.

Drug: Placebo

Interventions

Edaravone dexborneol DRUG

Edaravone dexborneol injection 37.5mg (edaravone 30mg and dexborneol 7.5mg) and 100ml of 0.9% saline every 12 hours for 7 days; sequentially a sublingual dose of edaravone dexborneol 36 mg (edaravone, 30 mg; dexborneol, 6 mg) twice a day for 21 days.

Edaravone dexborneol group

Placebo DRUG

Placebo injection every 12 hours for 7 days; sequentially a sublingual dose of placebo drug twice a day for 21 days.

Placebo 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 years old and ≤ 80 years old, regardless of gender;
• Patients diagnosed as acute ischemic stroke according to "key points for diagnosis of all kinds of major cerebrovascular diseases in China 2019", and able to randomise and initiate edaravone dexborneol treatment less than or equal to 48 hours of stroke onset.
• Total National Institute of Health stroke scale (NIHSS)≥6 and ≤24, and the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;
• modified Rankin Scale (mRS) score of 1 or less before onset.
• Did not receive edaravone dexborneol treatment before enrollment;
• The informed consent approved by the ethics committee was voluntarily signed by the patient or his legal representative.

You may not qualify if:

• Reperfusion therapy (intravenous thrombolysis and endovascular therapy) has been received or planned after stroke onset.
• Transient ischemic attack (TIA);
• Posterior circulation stroke;
• Intracranial hemorrhagic diseases seen in head imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc;
• Severe disturbance of consciousness: the item score of 1a consciousness level of NIHSS was more than 1;
• Patients with severe mental disorders and dementia;
• Systolic blood pressure after blood pressure control is still higher than 220mmhg or diastolic blood pressure was higher than 120mmhg;
• Severe cardiac insufficiency, dissection and acute pericarditis; Severe liver insufficiency, ALT or AST \> 3.0 × ULN; Or severe active liver diseases have been diagnosed, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc;Severe renal insufficiency, Serum Creatinine (SCr) is greater than 200μmol/L, Creatinine Clearance (CrCl) is less than 30 ml/min or receiving hemodialysis; Or suffering from severe systemic diseases, the estimated survival time is less than 90 days;
• Complicated with malignant tumor or undergoing anti-tumor treatment;
• Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase, Ginkgolide.
• Patients during pregnancy, lactation and planned pregnancy;
• Allergic to dexborneol or edaravone or excipients;
• Have participated in other clinical studies or are participating in other clinical studies within 30 days before randomization;
• Patients who are unwilling to be followed up，and the investigators consider the patients are not suitable for this trial.

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yi Yang, MD,PhD

CONTACT

13756661217; doctoryangyi@163.com

Zhen-Ni Guo, MD,PhD

CONTACT

18186872986; zhen1ni2@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice President of the First Hospital of Jilin University

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 17, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

CN (1)