A randomized, double-blind, placebo-controlled clinical study of CL2020 in ischemic stroke patient
Phase 2
Completed
- Conditions
- Ischemic stroke
- Registration Number
- JPRN-jRCT1080224042
- Lead Sponsor
- ife Science Institute, Inc
- Brief Summary
A single intravenous dose of CL2020 was administered to subjects with cerebral infarction, and they were observed until Week 52. No major safety problems were observed. The results of efficacy endpoints suggested the efficacy of CL2020 in patients with cerebral infarction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
[Major inclusion criteria]
1) Patients who can be registered between 14 and 28 days after onset of ischemic stroke
2) Patients who have moderate-to-severe neurological deficits, e.g., physical disabilities
3) Patients must have a score of the National Institutes of Health Stroke Scale of 6 or higher at registration.
Exclusion Criteria
[Major exclusion criteria]
1) Severe consciousness disturbance
2) Hemorrhagic transformation assessed by CT or MRI
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Safety after treatment with CL2020
- Secondary Outcome Measures
Name Time Method efficacy<br>Efficacy etc., after treatment with CL2020