Edaravone Dexborneol for Treatment of Hypertensive Intracerebral Hemorrhage (ED-ICH)
Primary Purpose
Intracerebral Hemorrhage
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Edaravone Dexborneol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Intracerebral Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- Written informed consent from the patient or legally acceptable representative
- Males and females
- Diagnose as hypertensive intracerebral hemorrhage
- Onset of symptoms within 6~48 hours
- Position of bleeding major in basal ganglia
- The sum of scores on items 5 and 6 on the NIHSS were >= 2 at baseline and the total score (items 1-11) was >=6 and <=20
- Volume of Hematoma <= 30 ml
- Premorbid mRS score of 0 or 1
Exclusion Criteria:
- Allergy to known study drugs or excipients
- Experienced stroke in latest 3 month
- Volume of Hematoma > 5 ml in other bleeding position
- Obstructive hydrocephalus
- Any diagnosis as other than hypertensive ICH
- Unconsciousness
- Severe concurrent illness with life expectancy less than 90 days
- Pregnancy or breast-feeding
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Edaravone Dexborneol
Placebo
Arm Description
Edaravone Dexborneol injection
Edaravone Dexborneol matching injection
Outcomes
Primary Outcome Measures
The proportionof Participants With modified Rankin Scale (mRS) 0 ~ 1
Secondary Outcome Measures
The proportion of death
The proportionof Participants With modified Rankin Scale (mRS)
The change in the NIH stroke scale (NIHSS) from the baseline
The proportionof Participants With Glasgow Outcome Score (GOS)
Barthel Index (BI)
Stroke Specific Quality of Life Scale (SS-QOL)
Full Information
NCT ID
NCT04714177
First Posted
January 15, 2021
Last Updated
January 15, 2021
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04714177
Brief Title
Edaravone Dexborneol for Treatment of Hypertensive Intracerebral Hemorrhage
Acronym
ED-ICH
Official Title
Efficacy and Safety of Edaravone Dexborneol in Addition to Standard of Care in Patients With Hypertensive Intracerebral Hemorrhage: a Randomized, Double-Blind, Placebo-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
pending
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
390 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Edaravone Dexborneol
Arm Type
Experimental
Arm Description
Edaravone Dexborneol injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Edaravone Dexborneol matching injection
Intervention Type
Drug
Intervention Name(s)
Edaravone Dexborneol
Intervention Description
Edaravone Dexborneol 37.5 mg, containing Edaravone 30 mg and Dexborneol 7.5 mg, Edaravone Dexborneol 37.5 mg BID, 14 days, addition to standard of care of Intracerebral Hemorrhage
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Edaravone Dexborneol matching injection, addition to standard of care of Intracerebral Hemorrhage
Primary Outcome Measure Information:
Title
The proportionof Participants With modified Rankin Scale (mRS) 0 ~ 1
Time Frame
90 days after the first dose of study treatment
Secondary Outcome Measure Information:
Title
The proportion of death
Time Frame
90 days after the first dose of study treatment
Title
The proportionof Participants With modified Rankin Scale (mRS)
Time Frame
14, 30 and 90 days after the first dose of study treatment
Title
The change in the NIH stroke scale (NIHSS) from the baseline
Time Frame
14, 30 and 90 days after the first dose of study treatment
Title
The proportionof Participants With Glasgow Outcome Score (GOS)
Time Frame
14, 30 and 90 days after the first dose of study treatment
Title
Barthel Index (BI)
Time Frame
90 days after the first dose of study treatment
Title
Stroke Specific Quality of Life Scale (SS-QOL)
Time Frame
90 days after the first dose of study treatment
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:
Written informed consent from the patient or legally acceptable representative
Males and females
Diagnose as hypertensive intracerebral hemorrhage
Onset of symptoms within 6~48 hours
Position of bleeding major in basal ganglia
The sum of scores on items 5 and 6 on the NIHSS were >= 2 at baseline and the total score (items 1-11) was >=6 and <=20
Volume of Hematoma <= 30 ml
Premorbid mRS score of 0 or 1
Exclusion Criteria:
Allergy to known study drugs or excipients
Experienced stroke in latest 3 month
Volume of Hematoma > 5 ml in other bleeding position
Obstructive hydrocephalus
Any diagnosis as other than hypertensive ICH
Unconsciousness
Severe concurrent illness with life expectancy less than 90 days
Pregnancy or breast-feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaofei Feng, MD
Phone
+86 18601203770
Email
xiaofeimed@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaofei Feng, MD
Phone
+86(25)8556 6366
12. IPD Sharing Statement
Learn more about this trial
Edaravone Dexborneol for Treatment of Hypertensive Intracerebral Hemorrhage
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