Efficacy, Safety, Tolerability and Pharmacokinetics of SUN13837 to Treat Acute Stroke

Withdrawn

Phase 2 Results N/A

Trial Description

The purpose of this study is to evaluate the safety and tolerability of SUN13837 and to determine whether SUN13837 improves the physical performance, relative to placebo, following an acute stroke in adult subjects.

Trial Stopped: study was stopped for business/administrative reasons and not for patient safety concerns

Conditions

Interventions

  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Placebo: Matching Placebo daily for 28 days
  • SUN13837 Drug
    ARM 1: Kind: Experimental
    Label: SUN13837
    Description: Drug: SUN13837 daily for 28 days.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Mean change from baseline in the Physical Performance Assessment in Stroke (PPAS) 84 days No
Secondary The proportion of responders as measured by the PPAS 84 days No
Secondary Mean change from baseline in PPAS Patient Reported Outcome Subscale 84 days No
Secondary Mean change from baseline in Short Form-36 Physical Functioning Scale (SF-36 PF) 84 days No
Secondary Mean change from baseline in Gait Speed 84 days No
Secondary Proportion of responders as measured by the Modified Rankin Scale (mRS) 84 days No
Secondary Safety/Tolerability - Number of Participants with Adverse Events 84 days Yes

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