Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04984577
• Other study ID #: NJYK-CPEDRV-II
• Status: Suspended
• Phase: Phase 2
• Start date: November 15, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Nanjing Yoko Biomedical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 240
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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
• Compound Edaravone Injection-High dose
Compound Edaravone Injection 50mg/dose (Edaravone 50mg, Taurine 1000 mg), one dose every 12 hours, continue for 14 days
• Edaravone Injection
Edaravone Injection 30mg/dose, one dose every 12 hours, continue for 14 days
• Placebo injection
Placebo injection, one dose every 12 hours, continue for 14 days

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital,Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Yoko Biomedical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with mRS =1 on day 90		day 90
Secondary	Changes of NIHSS score from baseline on day 14		day 14
Secondary	The proportion of patients with mRS =2 on day 90		day 90
Secondary	The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90		day 14, 30, 90
Secondary	The proportion of patients with ADL-BI =95 on day 14, 30, 90		day 14, 30, 90
Secondary	EQ-5D score on day 90		day 90
Secondary	Ordinal Distribution of mRS on day 90		day 90