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Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

NCT04984577 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2024-02-20

No results posted yet for this study

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

Interventions

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

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

DRUG

Edaravone Injection

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

DRUG

Placebo injection

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

Sponsors & Collaborators

  • Nanjing Yoko Biomedical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04984577 on ClinicalTrials.gov