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Modafinil for Post-Stroke Fatigue
NCT01800097Phase 3
Key facts
- Status
- Terminated
- Start
- Oct 2012
- Primary completion
- Mar 2015
- Countries
- 1
- Sponsor
- Herlev Hospital
- Modality
- Small Molecules
- Drugs
- modafinil
- Conditions
- post-stroke fatigue (PSF)
01
Overview
Phase 3, randomised, double-blind trial in post-stroke fatigue (PSF) comparing Modafinil with Placebo (2 arms). Primary endpoint: Multidimensional Fatigue Inventory at 3 months. Started Oct 2012; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Modafinil
Modafinil 400 mg (or 200 mg) daily
Placebo
Placebo daily
03
Who it enrols
Adult patients with stroke within 14 days, MFI-20 score >= 12, and no dementia or other fatigue-causing diseases.
04
Endpoints
Primary
Multidimensional Fatigue Inventory
Secondary
Multidimensional Fatigue Inventory
Fatigue Severity Scale
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