Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke

Completed

Phase 2 Results

Trial Description

The objectives of this study are to assess the safety, tolerability and local tolerance, and to investigate the plasma levels and terminal elimination half life of MCI-186, and to review the routine clinical and neurological assessments data of MCI-186 in subjects with acute ischemic stroke.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Cohort1:circa 1000mg / 72-hour infusion matching placebo Cohort2:circa 2000mg / 72-hour infusion matching placebo
    ARM 1: Kind: Experimental
    Label: 2 Placebo
    ARM 2: Kind: Experimental
    Label: Placebo Group
  • MCI-186 Drug
    Other Names: Edaravone
    Intervention Desc: Cohort 1: Edaravone: circa 1000 mg / 72-hour infusion Cohort 2: Edaravone: circa 2000 mg / 72-hour infusion
    ARM 1: Kind: Experimental
    Label: 1 MCI-186
    ARM 2: Kind: Experimental
    Label: MCI-186

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Adverse event, Adverse drug Reaction throughout study Yes
Secondary Plasma MCI-186 pharmacokinetics 96 hours No
Secondary mRS, NIHSS, Barthel Index throughout study No
Primary Number of Participants That Experienced Adverse Events 87days Yes

Sponsors