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Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent

This study is currently recruiting participants.
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Stroke
Post Stroke Fatigue
 Drug: modafinil
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Post Stroke Fatigue With Modafinil, Effect on Rehabilitation, Fatigue and Bonemass Index

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Multidimensional Fatigue Inventory (MFI- 20) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Questionnaire


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Estimated Enrollment: 128
Study Start Date: October 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
placebo
 Drug: placebo
Tablets, 400 mg once daily ( 200 mg if age 65 or above)morning for 3 months.
Active Comparator: Modafinil
Modafinil
 Drug: modafinil
Tablet, 400 mg once daily, morning (200 mg if age 65 or above) for 3 months
Other Name: modiodal, provigil

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01800097

Locations
Denmark
Department of Neurology, Herlev Hospital, Recruiting
Herlev, Denmark, 2730
Contact: Mai Poulsen, MD     0045 38681167     mai.bang.poulsen@regionh.dk    
Contact: Karsten Overgaard, MD         karsten.overgaard@regionh.dk    
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Karsten Overgaard, MD Department of Neurology, Herlev Hospital
  More Information

No publications provided

Responsible Party: Karsten Overgaard, Principal Investigator, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01800097     History of Changes
Other Study ID Numbers: ModaA001
Study First Received: October 23, 2012
Last Updated: February 25, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Health and Medicines Authority

Keywords provided by Herlev Hospital:
stroke
fatigue
modafinil

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Fatigue
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
 Brain Infarction
Brain Ischemia
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on June 18, 2013