A Phase 4 Clinical Study to Investigate the Efficacy and Safety of Naloxone HCI IV in Patients With Stroke
Status:
Recruiting
Trial end date:
2023-02-23
Target enrollment:
Participant gender:
Summary
This clinical trial was planned for the purpose to re-evaluate the safety and efficacy of
naloxone hydrochloride in ischemic cerebral nerve disorders caused by stroke and cerebral
hemorrhage.
Eligible subjects will be randomized to the naloxone hydrochloride group or placebo group at
1:1 ratio.
Also, factors, such as disease subtype and severity, which might impact the efficacy
endpoints will be used to stratify.
- Stratification factor: cerebral infarction (NIHSS 5-15 points or 16-20 points) or cerebral
hemorrhage
Administration of investigational product should be started within 48 hours from the onset of
symptoms.
Subject receive the investigational product 7 consecutive times (for 7 days) in a single dose
of intravenous infusion for 24 hours.