Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent

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

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.

Study Overview

• Status: Terminated
• Conditions: Stroke; Post Stroke Fatigue
• Intervention / Treatment: Drug: placebo; Drug: modafinil

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Department of Neurology, Herlev Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age and stroke within 14 days
• Modified Rankin Scale 3 or under and Barthel 85 or over before stroke
• Person that can understand instruction and do tests and questionnaires on their own or with support
• has given informed consent
• MFI-20 score of 12 or more
• Infertile person or fertile women tested negative of pregnancy and using safe anticonception

Exclusion Criteria:

• Dementia or other neuropsychiatric disease making the person incapable of understanding instructions
• Other disease with fatigue as a known symptom
• stroke induced by trauma, infection or surgical procedure
• former drug abuse
• known contraindication to treatment with modafinil
• known active malignancy, benign intracranial tumor, subdural or epidural bleeding
• kidneydysfunction with creatinin more than 265 micromol/L or liver disease with ASAT (aspartate aminotransferase) elevated to more than 70 U/L for women or 100 U/L for men.
• allergy to project treatment
• use of benzodiazepin or antiepileptic drugs in a fixed dose. Sleeping pills not included.
• Patients threaded with ciclosporin or anti HIV medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo; Tablets, 400 mg once daily ( 200 mg if age 65 or above)morning for 3 months.
Active Comparator: Modafinil	Drug: modafinil; Tablet, 400 mg once daily, morning (200 mg if age 65 or above) for 3 months; Other Names: modiodal, provigil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multidimensional Fatigue Inventory (MFI- 20)	Questionnaire	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MFI-20	Questionnaire	1 month
MFI-20	Questionnaire	6 months
Fatigue severity scale (FSS)		3 months
FSS	Questionnaire	1 month
FSS	Questionnaire	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bone mineral density and musclemass from baseline to 3 months	DXA-scans. (dual energy x-ray absorptiometry)	3 months
Reactiontime	A special designed computerprogramme will be used to measure the patients reactiontime.	1 month
Stroke Specific Quality Of Life (SSQOL)	Questionnaire	3 months
Change in Barthel Index	score	3 months
Modified Ranking Scale	score	3 months
Multidimensional Depression Inventory	Questionnaire	3 months
Change in "Time up and go" and "chair to stand test" from baseline		3 months
Cognitive performance, Montreal Cognitive Assessment(MOCA)	test	3 months
Change in bone mineral density and musclemass from baseline to 6 months	DXA-scan	6 months
Reactiontime	A special designed computerprogramme will be used to measure the patients reactiontime.	3 months
Reactiontime	A special designed computerprogramme will be used to measure the patients reactiontime.	6 months
Stroke Specific Quality Of Life	Questionnaire	6 months
Change in Barthel Index		6 months
Modified Ranking Scale	score	6 months
Change in "Time up and go" and "chair to stand test" from baseline		6 months
Multidimensional Depression Inventory	Questionnaire	6 months
Cognitive performance, Montreal Cognitive Assessment(MOCA)	test	6 months
Stroke Specific Quality Of Life (SSQOL)	Questionnaire	1 month
Change in Barthel Index	score	1 month
Modified Ranking Scale	score	1 month
Multidimensional Depression Inventory	Questionnaire	1 month
Change in "Time up and go" and "chair to stand test" from baseline		1 month
Cognitive performance, Montreal Cognitive Assessment(MOCA)	test	1 month

Collaborators and Investigators

• Sponsor: Herlev Hospital

Publications and helpful links

General Publications

• Poulsen MB, Damgaard B, Zerahn B, Overgaard K, Rasmussen RS. Modafinil May Alleviate Poststroke Fatigue: A Randomized, Placebo-Controlled, Double-Blinded Trial. Stroke. 2015 Dec;46(12):3470-7. doi: 10.1161/STROKEAHA.115.010860. Epub 2015 Nov 3.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: October 23, 2012
• First Submitted That Met QC Criteria: February 25, 2013
• First Posted (Estimate): February 27, 2013

Study Record Updates

• Last Update Posted (Estimate): June 24, 2015
• Last Update Submitted That Met QC Criteria: June 23, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: fatigue; stroke; modafinil
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Fatigue; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Central Nervous System Stimulants; Wakefulness-Promoting Agents; Modafinil
• Other Study ID Numbers: ModaA001