Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

Phase II Trial of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke -- a Multi-center, Randomized, Double-blind, Parallel, Multi-doses and Active-controlled Study

The primary objective of the study is to confirm the efficacy of compound Edaravone Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the safety of compound Edaravone Injection for the AIS patients.

Study Overview

• Status: Suspended
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: Compound Edaravone Injection-Low dose; Drug: Compound Edaravone Injection-High dose; Drug: Edaravone Injection; Drug: Placebo injection

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Tiantan Hospital,Capital Medical University
    • Contact: Yongjun Wang, professor; Phone Number: 13911172565; Email: yongjunwang111@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Hospitalized patients, diagnosed of ischemic stroke;
• Onset of stroke is less than or equal to 48 hours;
• There are clear signs of neurological deficit: 4≤NIHSS score≤24, and also, the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;
• Patients signed written inform consent

Exclusion Criteria:

• Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage;
• Iatrogenic stroke;
• Severe disturbance of consciousness: NIHSS category 1a for consciousness is greater than 1；
• The mRS score prior to this onset is greater than 1;
• Transient ischemic attack (TIA);
• SBP after blood pressure control is still greater than or equal to 220 mmHg, or DBP after blood pressure control is still greater than or equal to 120 mmHg;
• Patients with severe mental disorders and dementia;
• ALT or AST is greater than 2.0×ULN; Serum Creatinine (SCr) is greater than 1.5×ULN or Creatinine Clearance (CrCl) is less than 50 ml/min;
• Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
• Thrombectomy or interventional therapy has been applied or planned after this onset;
• Patients with malignant tumors or receiving concurrent antitumor treatment;
• Patients with severe systemic disease, life expectancy is less than 90 days;
• Allergic to edaravone , taurine or related excipients;
• Pregnant or lactating women;
• Have major surgery within 4 weeks before enrollment and not recovered enough to start the study;
• Participated in other clinical studies within 30 days before randomization;
• The investigators consider the patients are not suitable for this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Injection	Drug: Placebo injection; Placebo injection, one dose every 12 hours, continue for 14 days
Experimental: Compound Edaravone Injection-Low dose	Drug: Compound Edaravone Injection-Low dose; Compound Edaravone Injection 30mg/dose (Edaravone 30mg, Taurine 600 mg), one dose every 12 hours, continue for 14 days
Experimental: Compound Edaravone Injection-High dose	Drug: Compound Edaravone Injection-High dose; Compound Edaravone Injection 50mg/dose (Edaravone 50mg, Taurine 1000 mg), one dose every 12 hours, continue for 14 days
Active Comparator: Edaravone Injection	Drug: Edaravone Injection; Edaravone Injection 30mg/dose, one dose every 12 hours, continue for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients with mRS ≤1 on day 90	day 90

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90	day 14, 30, 90
Changes of NIHSS score from baseline on day 14	day 14
The proportion of patients with mRS ≤2 on day 90	day 90
The proportion of patients with ADL-BI ≥95 on day 14, 30, 90	day 14, 30, 90
EQ-5D score on day 90	day 90
Ordinal Distribution of mRS on day 90	day 90

Collaborators and Investigators

• Sponsor: Nanjing Yoko Biomedical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neuroprotective Agents; Protective Agents; Antioxidants; Free Radical Scavengers; Edaravone
• Other Study ID Numbers: NJYK-CPEDRV-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No