A Phase 4 Clinical Study to Investigate the Efficacy and Safety of Naloxone HCI IV in Patients With Stroke

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.

Timeline

Start

2018-08-07

Primary completion

2022-10-25

Completion

2023-07-10

Drugs

Indications