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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Intracerebral Hemorrhage

Treatments: Drug: Edaravone Dexborneol; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04714177

SIM23-ICH-201

Details and patient eligibility

About

pending

Enrollment: 390 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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390 participants in 2 patient groups, including a placebo group

Edaravone Dexborneol

Experimental group

Description:

Edaravone Dexborneol injection

Treatment:

Drug: Edaravone Dexborneol

Placebo

Placebo Comparator group

Description:

Edaravone Dexborneol matching injection

Treatment:

Drug: Placebo