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Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Compound Edaravone Injection-Low dose
Compound Edaravone Injection-High dose
Edaravone Injection
Placebo injection
Sponsored by
Nanjing Yoko Biomedical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beijing Tiantan Hospital，Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Compound Edaravone Injection-Low dose

Compound Edaravone Injection-High dose

Edaravone Injection

Placebo Injection

Arm Description

Outcomes

Primary Outcome Measures

The proportion of patients with mRS ≤1 on day 90

Secondary Outcome Measures

Changes of NIHSS score from baseline on day 14
The proportion of patients with mRS ≤2 on day 90
The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90
The proportion of patients with ADL-BI ≥95 on day 14, 30, 90
EQ-5D score on day 90
Ordinal Distribution of mRS on day 90

Full Information

First Posted
July 29, 2021
Last Updated
July 29, 2021
Sponsor
Nanjing Yoko Biomedical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04984577
Brief Title
Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing Yoko Biomedical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Compound Edaravone Injection-Low dose
Arm Type
Experimental
Arm Title
Compound Edaravone Injection-High dose
Arm Type
Experimental
Arm Title
Edaravone Injection
Arm Type
Active Comparator
Arm Title
Placebo Injection
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Compound Edaravone Injection-Low dose
Intervention Description
Compound Edaravone Injection 30mg/dose (Edaravone 30mg, Taurine 600 mg), one dose every 12 hours, continue for 14 days
Intervention Type
Drug
Intervention Name(s)
Compound Edaravone Injection-High dose
Intervention Description
Compound Edaravone Injection 50mg/dose (Edaravone 50mg, Taurine 1000 mg), one dose every 12 hours, continue for 14 days
Intervention Type
Drug
Intervention Name(s)
Edaravone Injection
Intervention Description
Edaravone Injection 30mg/dose, one dose every 12 hours, continue for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo injection
Intervention Description
Placebo injection, one dose every 12 hours, continue for 14 days
Primary Outcome Measure Information:
Title
The proportion of patients with mRS ≤1 on day 90
Time Frame
day 90
Secondary Outcome Measure Information:
Title
Changes of NIHSS score from baseline on day 14
Time Frame
day 14
Title
The proportion of patients with mRS ≤2 on day 90
Time Frame
day 90
Title
The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90
Time Frame
day 14, 30, 90
Title
The proportion of patients with ADL-BI ≥95 on day 14, 30, 90
Time Frame
day 14, 30, 90
Title
EQ-5D score on day 90
Time Frame
day 90
Title
Ordinal Distribution of mRS on day 90
Time Frame
day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Beijing Tiantan Hospital，Capital Medical University
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongjun Wang, professor
Phone
13911172565
Email
yongjunwang111@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

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