Edaravone Dexborneol for Treatment of Hypertensive Intracerebral Hemorrhage (ED-ICH)

January 15, 2021 updated by: Jinsheng Zeng, MD, PhD, First Affiliated Hospital, Sun Yat-Sen University

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

pending

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

390

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Xiaofei Feng, MD
  • Phone Number: +86(25)8556 6366

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Edaravone Dexborneol
Edaravone Dexborneol injection
Drug: Edaravone Dexborneol
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
Placebo Comparator: Placebo
Edaravone Dexborneol matching injection
Drug: Placebo
Edaravone Dexborneol matching injection, addition to standard of care of Intracerebral Hemorrhage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportionof Participants With modified Rankin Scale (mRS) 0 ~ 1
Time Frame: 90 days after the first dose of study treatment
90 days after the first dose of study treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of death
Time Frame: 90 days after the first dose of study treatment
90 days after the first dose of study treatment
The proportionof Participants With modified Rankin Scale (mRS)
Time Frame: 14, 30 and 90 days after the first dose of study treatment
14, 30 and 90 days after the first dose of study treatment
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
14, 30 and 90 days after the first dose of study treatment
The proportionof Participants With Glasgow Outcome Score (GOS)
Time Frame: 14, 30 and 90 days after the first dose of study treatment
14, 30 and 90 days after the first dose of study treatment
Barthel Index (BI)
Time Frame: 90 days after the first dose of study treatment
90 days after the first dose of study treatment
Stroke Specific Quality of Life Scale (SS-QOL)
Time Frame: 90 days after the first dose of study treatment
90 days after the first dose of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Collaborators

Jiangsu Simcere Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

January 15, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIM23-ICH-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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