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Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent

NCT01800097 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2015-06-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

modafinil

Tablet, 400 mg once daily, morning (200 mg if age 65 or above) for 3 months

DRUG

placebo

Tablets, 400 mg once daily ( 200 mg if age 65 or above)morning for 3 months.

Sponsors & Collaborators

  • Herlev Hospital

    lead OTHER

Principal Investigators

  • Karsten Overgaard, MD · Department of Neurology, Herlev Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01800097 on ClinicalTrials.gov