Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

Sponsor

Nanjing Yoko Biomedical Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04984577

Collaborator

(none)

240

Enrollment

Location

Arms

Anticipated Duration (Months)

11.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Drug: Compound Edaravone Injection-Low dose Drug: Compound Edaravone Injection-High dose Drug: Edaravone Injection Drug: Placebo injection	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Phase Ⅲ Trial of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke -- a Multi-center, Randomized, Double-blind, Parallel, Multi-doses and Active-controlled Study

Anticipated Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Compound Edaravone Injection-Low dose	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
Experimental: Compound Edaravone Injection-High dose	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
Active Comparator: Edaravone Injection	Drug: Edaravone Injection Edaravone Injection 30mg/dose, one dose every 12 hours, continue for 14 days
Placebo Comparator: Placebo Injection	Drug: Placebo injection Placebo injection, one dose every 12 hours, continue for 14 days

Outcome Measures

Primary Outcome Measures

The proportion of patients with mRS ≤1 on day 90 [day 90]

Secondary Outcome Measures

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]
Ordinal Distribution of mRS on day 90 [day 90]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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;
Participated in other clinical studies within 30 days before randomization;
The investigators consider the patients are not suitable for this trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tiantan Hospital，Capital Medical University	Beijing		China

Sponsors and Collaborators

Nanjing Yoko Biomedical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nanjing Yoko Biomedical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04984577

Other Study ID Numbers:

NJYK-CPEDRV-II

First Posted:

Jul 30, 2021

Last Update Posted:

Jul 30, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 30, 2021