A Phase 2, Double-blind Study of S-005151 in Patients with Acute Ischemic Stroke

JRCT ID: jRCT2080224879

Registered date:18/09/2019

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Acute Ischemic Stroke
• Date of first enrollment: 04/11/2019
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : S-005151
INN of investigational material : Redasemtide
Therapeutic category code : 49- Other agents affecting cellular function
Dosage and Administration for Investigational material : Intravenous injection

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome

efficacy
mRS 90 days after the first dose

Secondary Outcome

safety
efficacy
Main Secondary Outcome

Safety
- Adverse events, vital signs (blood pressure, pulse rate, body temperature, respiratory rate), electrocardiogram, clinical laboratory tests

Efficacy
- mRS at each visit other than day 90
- Proportion of subjects with mRS of <=1, <=2, and 5 or 6 at each visit
etc

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: <= 84age old
• Gender: Both

Include criteria

Main Inclusion Criteria
- Patients diagnosed with supratentorial ischemic stroke on magnetic resonance imaging (MRI)
- Patients who can be enrolled within 24 hours from 4.5 hours after the onset of ischemic stroke
- Patients with neurologic signs corresponding to 8-22 on the National Institute of Health Stroke Scale (NIHSS) score and who have not experienced a rapid change in neurologic signs within 30 minutes before enrollment
etc

Exclude criteria

Main Exclusion Criteria
- Patients with a disability corresponding to mRS score of >=2 before the onset of ischemic stroke
- Patients who have undergone thrombolysis or intravascular recanalization therapy within 90 days before obtaining informed consent.
- Patients with a history of stroke or intracranial hemorrhage that caused neurological events within 90 days before obtaining informed consent.
- Patients diagnosed with a transient ischemic attack
- Patients who cannot have MRI
etc

Related Information

• Primary Sponsor: SHIONOGI & CO., LTD.
• Secondary Sponsor: -
• Source(s) of Monetary Support: -
• Secondary ID(s): JapicCTI-194963