Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

NCT04984577 | Suspended Phase 2

• 1 other identifier: NJYK-CPEDRV-II
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with mRS ≤1 on day 90

  day 90

Secondary Outcomes (6)

• 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 NIHSS score 0-1 (including motor function) on day 14, 30, 90

  day 14, 30, 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

Study Arms (4)

Compound Edaravone Injection-Low dose

EXPERIMENTAL

Drug: Compound Edaravone Injection-Low dose

Compound Edaravone Injection-High dose

EXPERIMENTAL

Drug: Compound Edaravone Injection-High dose

Edaravone Injection

ACTIVE COMPARATOR

Drug: Edaravone Injection

Placebo Injection

PLACEBO COMPARATOR

Drug: Placebo injection

Interventions

Compound Edaravone Injection-Low dose DRUG

Compound Edaravone Injection 30mg/dose (Edaravone 30mg, Taurine 600 mg), one dose every 12 hours, continue for 14 days

Compound Edaravone Injection-Low dose

Compound Edaravone Injection-High dose DRUG

Compound Edaravone Injection 50mg/dose (Edaravone 50mg, Taurine 1000 mg), one dose every 12 hours, continue for 14 days

Compound Edaravone Injection-High dose

Edaravone Injection DRUG

Edaravone Injection 30mg/dose, one dose every 12 hours, continue for 14 days

Edaravone Injection

Placebo injection DRUG

Placebo injection, one dose every 12 hours, continue for 14 days

Placebo Injection

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Nanjing Yoko Biomedical Co., Ltd.: lead

Study Sites (1)

Beijing Tiantan Hospital，Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Edaravone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antipyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: July 29, 2021
• First Posted: July 30, 2021
• Study Start: November 15, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)