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Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent

This study has been terminated.
(Slow recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01800097
First Posted: February 27, 2013
Last Update Posted: June 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Karsten Overgaard, Herlev Hospital
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Karsten Overgaard, Herlev Hospital:

Primary Outcome Measures:
  • Multidimensional Fatigue Inventory (MFI- 20) [ Time Frame: 3 months ]
    Questionnaire


Secondary Outcome Measures:
  • MFI-20 [ Time Frame: 1 month ]
    Questionnaire

  • MFI-20 [ Time Frame: 6 months ]
    Questionnaire

  • Fatigue severity scale (FSS) [ Time Frame: 3 months ]
  • FSS [ Time Frame: 1 month ]
    Questionnaire

  • FSS [ Time Frame: 6 months ]
    Questionnaire


Other Outcome Measures:
  • Change in bone mineral density and musclemass from baseline to 3 months [ Time Frame: 3 months ]
    DXA-scans. (dual energy x-ray absorptiometry)

  • Reactiontime [ Time Frame: 1 month ]
    A special designed computerprogramme will be used to measure the patients reactiontime.

  • Stroke Specific Quality Of Life (SSQOL) [ Time Frame: 3 months ]
    Questionnaire

  • Change in Barthel Index [ Time Frame: 3 months ]
    score

  • Modified Ranking Scale [ Time Frame: 3 months ]
    score

  • Multidimensional Depression Inventory [ Time Frame: 3 months ]
    Questionnaire

  • Change in "Time up and go" and "chair to stand test" from baseline [ Time Frame: 3 months ]
  • Cognitive performance, Montreal Cognitive Assessment(MOCA) [ Time Frame: 3 months ]
    test

  • Change in bone mineral density and musclemass from baseline to 6 months [ Time Frame: 6 months ]
    DXA-scan

  • Reactiontime [ Time Frame: 3 months ]
    A special designed computerprogramme will be used to measure the patients reactiontime.

  • Reactiontime [ Time Frame: 6 months ]
    A special designed computerprogramme will be used to measure the patients reactiontime.

  • Stroke Specific Quality Of Life [ Time Frame: 6 months ]
    Questionnaire

  • Change in Barthel Index [ Time Frame: 6 months ]
  • Modified Ranking Scale [ Time Frame: 6 months ]
    score

  • Change in "Time up and go" and "chair to stand test" from baseline [ Time Frame: 6 months ]
  • Multidimensional Depression Inventory [ Time Frame: 6 months ]
    Questionnaire

  • Cognitive performance, Montreal Cognitive Assessment(MOCA) [ Time Frame: 6 months ]
    test

  • Stroke Specific Quality Of Life (SSQOL) [ Time Frame: 1 month ]
    Questionnaire

  • Change in Barthel Index [ Time Frame: 1 month ]
    score

  • Modified Ranking Scale [ Time Frame: 1 month ]
    score

  • Multidimensional Depression Inventory [ Time Frame: 1 month ]
    Questionnaire

  • Change in "Time up and go" and "chair to stand test" from baseline [ Time Frame: 1 month ]
  • Cognitive performance, Montreal Cognitive Assessment(MOCA) [ Time Frame: 1 month ]
    test


Enrollment: 41
Study Start Date: October 2012
Study Completion Date: March 2015
Primary Completion Date: March 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800097


Locations
Denmark
Department of Neurology, Herlev Hospital,
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Karsten Overgaard, MD Department of Neurology, Herlev Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karsten Overgaard, Principal Investigator, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01800097     History of Changes
Other Study ID Numbers: ModaA001
First Submitted: October 23, 2012
First Posted: February 27, 2013
Last Update Posted: June 24, 2015
Last Verified: June 2015

Keywords provided by Karsten Overgaard, Herlev Hospital:
stroke
fatigue
modafinil

Additional relevant MeSH terms:
Stroke
Fatigue
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Modafinil
Armodafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs