Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Herlev Hospital
Sponsor:
Information provided by (Responsible Party):
Karsten Overgaard, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01800097
First received: October 23, 2012
Last updated: February 25, 2013
Last verified: February 2013

October 23, 2012
February 25, 2013
October 2012
May 2015   (final data collection date for primary outcome measure)
Multidimensional Fatigue Inventory (MFI- 20) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Questionnaire
Same as current
Complete list of historical versions of study NCT01800097 on ClinicalTrials.gov Archive Site
  • MFI-20 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Questionnaire
  • MFI-20 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Questionnaire
  • Fatigue severity scale (FSS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • FSS [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Questionnaire
  • FSS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Questionnaire
Same as current
  • Change in bone mineral density and musclemass from baseline to 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    DXA-scans. (dual energy x-ray absorptiometry)
  • Reactiontime [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    A special designed computerprogramme will be used to measure the patients reactiontime.
  • Stroke Specific Quality Of Life (SSQOL) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Questionnaire
  • Change in Barthel Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    score
  • Modified Ranking Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    score
  • Multidimensional Depression Inventory [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Questionnaire
  • Change in "Time up and go" and "chair to stand test" from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Cognitive performance, Montreal Cognitive Assessment(MOCA) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    test
  • Change in bone mineral density and musclemass from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    DXA-scan
  • Reactiontime [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    A special designed computerprogramme will be used to measure the patients reactiontime.
  • Reactiontime [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    A special designed computerprogramme will be used to measure the patients reactiontime.
  • Stroke Specific Quality Of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Questionnaire
  • Change in Barthel Index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Modified Ranking Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    score
  • Change in "Time up and go" and "chair to stand test" from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Multidimensional Depression Inventory [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Questionnaire
  • Cognitive performance, Montreal Cognitive Assessment(MOCA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    test
  • Stroke Specific Quality Of Life (SSQOL) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Questionnaire
  • Change in Barthel Index [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    score
  • Modified Ranking Scale [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    score
  • Multidimensional Depression Inventory [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Questionnaire
  • Change in "Time up and go" and "chair to stand test" from baseline [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Cognitive performance, Montreal Cognitive Assessment(MOCA) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    test
Same as current
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Stroke
  • Post Stroke Fatigue
  • Drug: modafinil
    Tablet, 400 mg once daily, morning (200 mg if age 65 or above) for 3 months
    Other Name: modiodal, provigil
  • Drug: placebo
    Tablets, 400 mg once daily ( 200 mg if age 65 or above)morning for 3 months.
  • Placebo Comparator: placebo
    placebo
    Intervention: Drug: placebo
  • Active Comparator: Modafinil
    Modafinil
    Intervention: Drug: modafinil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
128
August 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Denmark
 
NCT01800097
ModaA001
Yes
Karsten Overgaard, Herlev Hospital
Herlev Hospital
Not Provided
Principal Investigator: Karsten Overgaard, MD Department of Neurology, Herlev Hospital
Herlev Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP