Edaravone Dexborneol for Treatment of Hypertensive Intracerebral Hemorrhage
ED-ICH
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
1 other identifier
interventional
390
0 countries
N/A
Brief Summary
pending
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2021
CompletedFirst Posted
Study publicly available on registry
January 19, 2021
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedJanuary 19, 2021
January 1, 2021
2 years
January 15, 2021
January 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The proportionof Participants With modified Rankin Scale (mRS) 0 ~ 1
90 days after the first dose of study treatment
Secondary Outcomes (6)
The proportion of death
90 days after the first dose of study treatment
The proportionof Participants With modified Rankin Scale (mRS)
14, 30 and 90 days after the first dose of study treatment
The change in the NIH stroke scale (NIHSS) from the baseline
14, 30 and 90 days after the first dose of study treatment
The proportionof Participants With Glasgow Outcome Score (GOS)
14, 30 and 90 days after the first dose of study treatment
Barthel Index (BI)
90 days after the first dose of study treatment
- +1 more secondary outcomes
Study Arms (2)
Edaravone Dexborneol
EXPERIMENTALEdaravone Dexborneol injection
Placebo
PLACEBO COMPARATOREdaravone Dexborneol matching injection
Interventions
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
Edaravone Dexborneol matching injection, addition to standard of care of Intracerebral Hemorrhage
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 15, 2021
First Posted
January 19, 2021
Study Start
March 1, 2021
Primary Completion
March 1, 2023
Study Completion
September 1, 2023
Last Updated
January 19, 2021
Record last verified: 2021-01