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

April 17, 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 NCT00884481 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 ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effects of Tysabri Over 12 Months on MS Related Fatigue in Patients With 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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Fatigue
  • Relapsing Remitting Multiple Sclerosis
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
Tests and questionnaires
Measuring MS related fatigue over the first 12 months following initiation of treatment with TYSABRI
Intervention: Other: tests and questionnaires
Svenningsson A, Falk E, Celius EG, Fuchs S, Schreiber K, Berkö S, Sun J, Penner IK; Tynergy Trial Investigators. Natalizumab treatment reduces fatigue in multiple sclerosis. Results from the TYNERGY trial; a study in the real life setting. PLoS One. 2013;8(3):e58643. doi: 10.1371/journal.pone.0058643. Epub 2013 Mar 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00884481
2008-008065-35
No
Dr Anders Svenningsson, Norrlands University Hospital
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