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Effect of Early Versus Late Initiation of Edaravone Dexborneol on Neural Function in Patients With Acute Ischemic Stroke

NCT05885919 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2023-06-27

No results posted yet for this study

Summary

The primary objective of this study was to evaluate the efficacy and safety of initiation of edaravone dextivel therapy compared with placebo in patients with acute ischaemic stroke (early and late) and to explore the optimal time window for "brain cell protective therapy" of edaravone dexborneol.

Conditions

  • Ischemic Stroke, Acute
  • Treatment Outcome

Interventions

DRUG

Edaravone Dexborneol Concentrated Solution for injection

Edaravone and Dexborneol Concentrated Solution for Injection, 15 ml (37.5 mg, containing edaravone 30 mg and dexborneol 7.5 mg) in 3 ampoule bottles, twice a day for 10 to 14 days.

DRUG

Edaravone Dexborneol placebo

Edaravone and Dexborneol placebo, 15 ml in 3 ampoule bottles, twice a day for 10 to 14 days.

Sponsors & Collaborators

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Xiangya Hospital of Central South University

    lead OTHER

Principal Investigators

  • Zhang Le, PhD · Department of Neurology，XiangYa School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-12-31
Completion
2024-12-31

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 NCT05885919 on ClinicalTrials.gov