Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

Phase 2

Suspended

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Compound Edaravone Injection-Low dose; Drug: Placebo injection; Drug: Compound Edaravone Injection-High dose; Drug: Edaravone Injection

• Registration Number: NCT04984577
• Lead Sponsor: Nanjing Yoko Biomedical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-07-30
• Study Start: 2021-11-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-18
• Last Update Posted: 2024-02-20
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compound Edaravone Injection-Low dose	Compound Edaravone Injection-Low dose	-
Placebo Injection	Placebo injection	-
Compound Edaravone Injection-High dose	Compound Edaravone Injection-High dose	-
Edaravone Injection	Edaravone Injection	-

Primary Outcome Measures

Name	Time	Method
The proportion of patients with mRS ≤1 on day 90	day 90

Secondary Outcome Measures

Name	Time	Method
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
The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90	day 14, 30, 90

Trial Locations

Locations (1)

Beijing Tiantan Hospital，Capital Medical University; 🇨🇳 Beijing, China