Suspended

Treatment of Post Stroke Fatigue With Modafinil, Effect on Rehabilitation, Fatigue and Bonemass Index

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What is being tested

placebo

+ modafinil

Drug
Who is being recruted

Brain Diseases+7

+ Cardiovascular Diseases

+ Central Nervous System Diseases

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorHerlev Hospital
Last updated: June 24, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01800097
Principal SponsorHerlev Hospital
Last updated: June 24, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

41 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesFatigueStroke

Criteria

6 inclusion criteria required to participate
18 years of age and stroke within 14 days
Infertile person or fertile women tested negative of pregnancy and using safe anticonception
MFI-20 score of 12 or more
Modified Rankin Scale 3 or under and Barthel 85 or over before stroke
Show More Criteria
10 exclusion criteria prevent from participating
Dementia or other neuropsychiatric disease making the person incapable of understanding instructions
Other disease with fatigue as a known symptom
Patients threaded with ciclosporin or anti HIV medication
allergy to project treatment
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
placebo

Group II

Active Comparator
Modafinil

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Neurology, Herlev Hospital,

Herlev, DenmarkOpen Department of Neurology, Herlev Hospital, in Google Maps
SuspendedOne Study Center