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Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke

NCT06645522 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2024-10-17

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke.

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

Edaravone dexborneol

Edaravone dexborneol injection 37.5mg (edaravone 30mg and dexborneol 7.5mg) and 100ml of 0.9% saline every 12 hours for 7 days; sequentially a sublingual dose of edaravone dexborneol 36 mg (edaravone, 30 mg; dexborneol, 6 mg) twice a day for 21 days.

DRUG

Placebo

Placebo injection every 12 hours for 7 days; sequentially a sublingual dose of placebo drug twice a day for 21 days.

Sponsors & Collaborators

  • Yi Yang

    lead OTHER

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
2024-10-30
Primary Completion
2026-10-30
Completion
2027-01-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06645522 on ClinicalTrials.gov