Edaravone Dexborneol for Treatment of Hypertensive Intracerebral Hemorrhage

Phase 2

• Conditions: Intracerebral Hemorrhage
• Interventions: Drug: Edaravone Dexborneol; Drug: Placebo

• Registration Number: NCT04714177
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Brief Summary

pending

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-15
• Last Update Submitted: 2021-01-15
• Study First Posted: 2021-01-19
• Last Update Posted: 2021-01-19
• Study Start: 2021-03-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 390

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Edaravone Dexborneol	Edaravone Dexborneol	Edaravone Dexborneol injection
Placebo	Placebo	Edaravone Dexborneol matching injection

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Stroke Specific Quality of Life Scale (SS-QOL)	90 days after the first dose of study treatment
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