A Phase 3 interventional study of Edaravone Dexborneol Concentrated Solution for injection and Edaravone Dexborneol placebo in Ischemic Stroke, Acute and Treatment Outcome, sponsored by Xiangya Hospital of Central South University. Status unknown at 3 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-27.
Sponsored by Xiangya Hospital of Central South University · Phase 3, Interventional, and Treatment
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.
This is a multicentre, randomized, double-blind, placebo-controlled trial that aims to investigate the efficacy and safety of (early and late) initiation treatment of Edaravone Dexborneol versus placebo in patients with acute ischemic stroke, and to explore the optimal time window for "brain cell protective therapy" of Edaravone Dexborneol. Patients who were eligible to the inclusion criteria and ineligible to the exclusion criteria will be stratified by time to trial drug: early (\<3 hours) and late (3-6 hours). Then each layer will be randomly assigned into two groups by a 1:1 ratio after the ICF was received. Patients in one arm will be given 15ml edaravone and dexborneol concentrated solution for injection (37.5mg, containing edaravone 30mg and dexborneol 7.5mg) twice a day for 10-14 days, and those in the other arm will be given an equivalent placebo drug. All patients will be followed up for 90 days. The primary outcome is the proportion of modified Rankin Scale 0-2 and the safety outcome is the proportion of severe adverse events.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 212 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Xiangya Hospital of Central South University is the lead sponsor of 170 studies on the registry; 76 are open to participants now.
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Exclusion Criteria:
Patients in this arm will be given Edaravone Dexborneol Concentrated Solution for injection twice a day for 10 to 14 days.
Drug: Edaravone Dexborneol Concentrated Solution for injection
Patients in this arm will be given a placebo of Edaravone Dexborneol for injection twice a day for 10 to 14 days
Drug: Edaravone Dexborneol placebo
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.
Also known as: Xian Bi Xin,CFDA Approval Number H20200007
Edaravone and Dexborneol placebo, 15 ml in 3 ampoule bottles, twice a day for 10 to 14 days.
Also known as: Xian Bi Xin placebo
A 90-day mRS score of 0 to 2 in participants with acute ischaemic stroke
To assess the proportion of participants (early and late) who started edaravone dextrol compared with placebo with a 90-day mRS score of 0 to 2 in participants with acute ischaemic stroke
Time frame: 90 days
Neurological recovery
The difference value of the NIHSS between Day 14/Day 90 and the baseline.
Time frame: 90 days
Modified Rankin scale
used to evaluate the functional outcomes after AIS，good prognosis (mRS score 0-2), generally good prognosis (mRS score 3-4) , Poor prognosis (mRS \>4 points).
Time frame: 90 days
Quality of life score (EQ-5D)
Generic health status evaluated by EQ-5D questionnaire at the end of the therapy.
Time frame: 90 days
The incidence of serious adverse events
The percentage of the Severity Adverse Events within the 14 days/90 days of the therapy.
Time frame: 90 days
All-cause mortality
All-cause mortality at 90 days after randomization
Time frame: 90 days
Plan to share: No
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Xiangya Hospital of Central South University