Actively Recruiting
A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Phase Ⅲ Clinical Trial Evaluating the Efficacy and Safety of BXOS110 Injection in the Treatment of Acute Ischaemic Stroke Within 3 Hours of Onset.
Led by Biocells (Beijing) Biotech Co.,Ltd · Updated on 2026-04-09
1112
Participants Needed
9
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study was to evaluate the efficacy of early administration of BXOS110 for injection in reducing overall disability in patients with acute ischaemic stroke
CONDITIONS
Official Title
A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Phase Ⅲ Clinical Trial Evaluating the Efficacy and Safety of BXOS110 Injection in the Treatment of Acute Ischaemic Stroke Within 3 Hours of Onset.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 85 years, any gender
- Diagnosed with acute ischaemic stroke according to Chinese clinical guidelines
- NIHSS score between 8 and 25 before randomisation, including at least 2 points in limb motor scores
- Stroke onset within 3 hours and able to start treatment within 3 hours of onset
- First stroke or previous stroke with good recovery (mRS score 3 or less)
- Able to understand and comply with study procedures and provide written informed consent or have a legal representative do so
You will not qualify if you...
- Imaging confirmed intracranial hemorrhagic disease
- Severe disturbance of consciousness (NIHSS 1a score 2 or more)
- Uncontrolled hypertension after treatment (systolic 180 mmHg or diastolic 110 mmHg)
- Severe hyperglycemia or hypoglycemia (blood glucose 400 mg/dL or 30 mg/dL)
- Heart rate less than 50 or greater than 120 beats per minute; recent serious heart conditions
- Severe liver or kidney dysfunction affecting participation
- Malignant tumors or anti-tumor treatment within past 5 years
- Neuroprotective agents used after current stroke onset
- History or current epilepsy related to stroke
- Mental illness preventing cooperation
- Limb movement dysfunction affecting neurological tests
- Severe head trauma or stroke within 3 months before screening
- Severe allergies or known allergy to study drug
- Expected survival less than 3 months
- Pregnant, planning pregnancy, or breastfeeding
- History of alcohol or drug abuse
- Participation in another clinical trial within 1 month
- Other conditions judged by investigators to increase risk or be inappropriate for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Harrison International Peace Hospital
Hengshui, Hebei, China
Actively Recruiting
2
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
Actively Recruiting
3
The First Affiliated Hospital of Nanyang Medicinal College
Nanyang, Henan, China
Actively Recruiting
4
MeiHekou Central Hospital
Meihekou, Jilin, China
Actively Recruiting
5
The Affiliated Hospital of Shenyang Medical College
Shenyang, Liaoning, China
Actively Recruiting
6
Xianyang Hospital of Yan'an University
Xianyang, Shaanxi, China
Actively Recruiting
7
Linyi People's Hospital
Linyi, Shandong, China
Actively Recruiting
8
Linfen Central Hospital
Linfen, Shanxi, China
Not Yet Recruiting
9
Beijing Tiantan Hospital , Capital Medical University
Beijing, China
Not Yet Recruiting
Research Team
M
ming xiao zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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