Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke

Completed

Phase 2 Results N/A

Trial Description

Armodafinil is an FDA approved medication with wakefulness-promoting properties. It is a relatively safe agent with interesting neurochemical effects on the catecholamine system, producing an improvement in cognitive function, particularly working memory in humans. When combined with intensive task-related training, armodafinil may accelerate motor recovery in chronic stroke patients.
The primary aim of this study is to determine whether administration of armodafinil during subacute post-stroke rehabilitation will augment cortical plasticity and enhance motor recovery. The primary hypothesis suggests that cortical plasticity will be enhanced by armodafinil and, therefore, will induce an improvement in motor function and better performances on measures of motor control.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: inactive pill manufactured to mimic Armodafinil 150 mg tablet
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
  • Armodafinil Drug
    Other Names: Nuvigil
    ARM 1: Kind: Experimental
    Label: Armodafinil
    Description: 150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Fugl-Meyer Assessment of Sensorimotor Function from Baseline to Discharge Day 12 No
Primary Change in Functional Independence Measure (FIM) from Baseline to Discharge Day 12 No
Primary Change in Fugl-Meyer Assessment of Sensorimotor Function from Baseline to Day 100 Day 100 No
Primary Change in Functional Independence Measure (FIM) from Baseline to Day 100 Day 100 No
Secondary Timed 3-Minute Walk Test Day 1, Day 12, Day 50, Day 100 No
Secondary NIH Stroke Scale (NIHSS) Day 1, Day 12, Day 100 No
Secondary 9-Hole Peg Test Day 1, Day 12, Day 50, Day 100 No

Sponsors