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
  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
Fatigue

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:


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 ]

Enrollment: 60
Study Start Date: April 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

RRMS patients

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966797

Locations
Norway
Oslo Universitetssygehus, Ullevål
Oslo, Norway, N407
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Dr Elisabeth Celius, Oslo University Hospital, Norway
ClinicalTrials.gov Identifier: NCT00966797     History of Changes
Other Study ID Numbers: 2008-008065-35 amended
Study First Received: August 26, 2009
Last Updated: November 3, 2011
Health Authority: Austria: Agentur für Gesundheit und Ernärungssicherheit GmbH
Norway: Statens Legemiddelsverk

Keywords provided by Biogen Idec:
Fatigue

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

ClinicalTrials.gov processed this record on September 15, 2014