Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent

Terminated

Phase 3 Results N/A

Trial Description

This study is an investigator initiated placebo controlled double blinded trial. The hypothesis is that treatment with modafinil positively will affect behavioural and cognitive rehabilitation after stroke, causing the treatment group to experience decreased fatigue, increased endurance, improved skills of sustaining attention and faster reaction times. The cognitive rehabilitation will show in increased muscle mass, decreased osteoporosis and better physical performances due to a higher level of physical activity.

Trial Stopped: Slow recruitment

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Tablets, 400 mg once daily ( 200 mg if age 65 or above)morning for 3 months.
    ARM 1: Kind: Experimental
    Label: placebo
    Description: placebo
  • Modafinil Drug
    Other Names: Provigil
    Intervention Desc: Tablet, 400 mg once daily, morning (200 mg if age 65 or above) for 3 months
    ARM 1: Kind: Experimental
    Label: Modafinil
    Description: Modafinil

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Multidimensional Fatigue Inventory (MFI- 20) 3 months No
Secondary MFI-20 1 month No
Secondary Fatigue severity scale (FSS) 3 months No
Secondary FSS 1 month No

Sponsors