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Effects of Tysabri Over 12 Months on MS Related Fatigue in Patients With RRMS (TYNERGY)

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00884481
First received: April 17, 2009
Last updated: November 3, 2011
Last verified: November 2011
History of Changes
  Purpose

Fatigue is a problem in 75-95% of MS patients and many report fatigue as one of their most disabling symptoms which contributes to cognitive and physical difficulties. Treatment that can decrease fatigue will improve the quality of life for this group of patients. Small studies and anecdotal reports have suggested that TYSABRI as opposed to other disease modifying therapies can decrease fatigue in MS patients. Data from a more substantial trial population and a well-defined fatigue scale is warranted to verify these observations.


Condition Intervention Phase
Fatigue
Relapsing Remitting Multiple Sclerosis
 Other: tests and questionnaires
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-centre and Prospective Trial to Evaluate the Effects on Multiple Sclerosis Related Fatigue During Treatment With Tysabri in Patients With Relapsing Remitting Multiple Sclerosis Over the Course of 12 Months

Resource links provided by NLM:

Drug Information available for: Natalizumab
U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • To investigate the MS related fatigue during treatment with TYSABRI as measured by changes in the fatigue scale for motor and cognitive functions (FMSC) over the course of 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in fatigue, capacity for work, HRQoL, sleepiness, cognitive impairment, physical activity induced exhaustion, speed of walking, status of MS disease progression and amount of walking at different time points after initiation of TYSABRI treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To investigate correlation between fatigue and cognitive impairment, depression and physically activity induced exhaustion and status of MS disease progression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To document any changes in fatigue related medication [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: April 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tests and questionnaires
Measuring MS related fatigue over the first 12 months following initiation of treatment with TYSABRI
 Other: tests and questionnaires
measuring fatigue, capacity for work, health related quality of life, sleepiness, depression, cognitive impairment, physical activity induced exhaustion, speed od walking, status of MS disease progression and amount of walking.
Other Names:
  • 6MWT
  • BS-CR10
  • CES-D
  • CWQ
  • EDSS
  • ESS
  • FSMC
  • PASAT
  • SDMT
  • SF-12

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 and < 65 at screening
  • TYSABRI prescribed according to national guidelines but not yet started treatment
  • Signed informed consent form
  • FSMC sum score above 43 at baseline (mild fatigue)

Exclusion Criteria:

  • FSMC sum score below 43 at baseline
  • History of treatment with TYSABRI
  • EDSS > 6 at baseline
  • Amphetamine as medication
  • Major depression
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884481

Locations
Sweden
Norrlands Universitets Sjukhus
Umeå, Sweden, 90185
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Dr Anders Svenningsson, Norrlands University Hospital
ClinicalTrials.gov Identifier: NCT00884481     History of Changes
Other Study ID Numbers: 2008-008065-35
Study First Received: April 17, 2009
Last Updated: November 3, 2011
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Fatigue
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Signs and Symptoms
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013