ED-ICH: Edaravone Dexborneol for Treatment of Hypertensive Intracerebral Hemorrhage

Sponsor

First Affiliated Hospital, Sun Yat-Sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04714177

Collaborator

Jiangsu Simcere Pharmaceutical Co., Ltd. (Industry)

390

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

pending

Condition or Disease	Intervention/Treatment	Phase
Intracerebral Hemorrhage	Drug: Edaravone Dexborneol Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

390 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The proportionof Participants With modified Rankin Scale (mRS) 0 ~ 1 [90 days after the first dose of study treatment]

Secondary Outcome Measures

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]
Stroke Specific Quality of Life Scale (SS-QOL) [90 days after the first dose of study treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

First Affiliated Hospital, Sun Yat-Sen University
Jiangsu Simcere Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jinsheng Zeng, MD, PhD, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University

ClinicalTrials.gov Identifier:

NCT04714177

Other Study ID Numbers:

SIM23-ICH-201

First Posted:

Jan 19, 2021

Last Update Posted:

Jan 19, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cerebral Hemorrhage

Intracranial Hemorrhage, Hypertensive

Hemorrhage

Edaravone

Study Results

No Results Posted as of Jan 19, 2021