Edaravone Dexborneol for Treatment of Hypertensive Intracerebral Hemorrhage

Study Overview
=================
Brief Summary
-----------------
pending

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

Conditions
-----------------
Intracerebral Hemorrhage

Intervention / Treatment
-----------------
* Drug: Edaravone Dexborneol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Edaravone Dexborneol<br>Edaravone Dexborneol injection | Drug: Edaravone Dexborneol<br>* 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<br>|
| Placebo Comparator: Placebo<br>Edaravone Dexborneol matching injection | Drug: Placebo<br>* Edaravone Dexborneol matching injection, addition to standard of care of Intracerebral Hemorrhage<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |