Edaravone Dexborneol for Treatment of Hypertensive Intracerebral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04714177
• Other study ID #: SIM23-ICH-201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: January 2021
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Xiaofei Feng, MD
• Phone: +86 18601203770
• Email: xiaofeimed[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

pending

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 390
• Est. completion date: September 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Intracranial Hemorrhage, Hypertensive

Intervention

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
Edaravone Dexborneol matching injection, addition to standard of care of Intracerebral Hemorrhage

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportionof Participants With modified Rankin Scale (mRS) 0 ~ 1		90 days after the first dose of study treatment
Secondary	The proportion of death		90 days after the first dose of study treatment
Secondary	The proportionof Participants With modified Rankin Scale (mRS)		14, 30 and 90 days after the first dose of study treatment
Secondary	The change in the NIH stroke scale (NIHSS) from the baseline		14, 30 and 90 days after the first dose of study treatment
Secondary	The proportionof Participants With Glasgow Outcome Score (GOS)		14, 30 and 90 days after the first dose of study treatment
Secondary	Barthel Index (BI)		90 days after the first dose of study treatment
Secondary	Stroke Specific Quality of Life Scale (SS-QOL)		90 days after the first dose of study treatment