Randomized, Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery

Completed

Phase 2 Results N/A

Trial Description

The purpose of this study is to determine the safety, tolerability, and to explore the possible benefit of extended-release niacin (Niaspan®) in attempting to improve the recovery of patients after ischemic stroke.

Detailed Description

The investigators are interested in extended-release niacin (Niaspan®) and its potential restorative role after ischemic stroke. At Henry Ford Hospital in Detroit, Michigan, extended-release niacin (Niaspan®) has been shown to improve the functional outcomes of rats when administered during the first two weeks after ischemic stroke onset. Such results are encouraging and warrant further investigation in humans. The specific aims of this study are to prospectively evaluate the use of extended-release niacin (Niaspan®) in a phase II clinical trial in patients with subacute ischemic stroke. The investigators will assess the safety and tolerability of Niaspan® and evaluate outcomes among treated patients at 24 weeks after ischemic stroke onset. This will be a randomized, double-blinded, placebo-controlled, safety, tolerability, and exploratory efficacy study of extended-release niacin (Niaspan®) in subacute ischemic stroke patients with both low HDL-C and normal HDL-C in cohort sizes of 16 patients. A total enrollment of 48 patients is planned. Patients who are between 72 hours and 7 days from stroke onset will receive Niaspan® 500mg, 1000mg, or placebo daily for a period of 24 weeks. Evaluation of potential safety and tolerability in subacute ischemic stroke patients will be made during the course of treatment and at formal visits at 6, 12, and 24 weeks. The primary safety measures will be death, recurrent stroke, myocardial infarction, and neurological worsening during treatment. Exploratory analysis will include functional outcomes on the NIHSS scores, modified Rankin scores, and Barthel indices at 24 weeks. The goal of this study is to improve the outcomes from ischemic stroke, using a safe and effective novel strategy of restoration, which has been translated from basic laboratory studies.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Placebo tablet once daily
    ARM 1: Kind: Experimental
    Label: Placebo
  • Extended-Release Niacin Drug
    Other Names: Niaspan®
    Intervention Desc: 1000mg tablet once daily
    ARM 1: Kind: Experimental
    Label: Niaspan® 500mg
    ARM 2: Kind: Experimental
    Label: Niaspan® 1000mg

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of expected serious adverse events 24 weeks Yes
Secondary Functional Recovery 24 weeks No

Sponsors