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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
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage

Eligibility Criteria

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

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

    First Posted
    January 15, 2021
    Last Updated
    January 15, 2021
    Sponsor
    First Affiliated Hospital, Sun Yat-Sen University
    Collaborators
    Jiangsu Simcere Pharmaceutical Co., Ltd.
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    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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