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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00966797
First received: August 26, 2009
Last updated: November 3, 2011
Last verified: November 2011

August 26, 2009
November 3, 2011
April 2009
October 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00966797 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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Effects of Tysabri Over 12 Months on Multiple Sclerosis (MS) Related Fatigue in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
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

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

RRMS patients

Fatigue
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 < 65 at screening
  • Tysabri prescribed according to national guidelines but not yet started treatment
  • Signed informed consent form
  • FSMS 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00966797
2008-008065-35 amended
Not Provided
Dr Elisabeth Celius, Oslo University Hospital, Norway
Biogen Idec
Not Provided
Not Provided
Biogen Idec
November 2011

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