NCT00884481

Brief Summary

The primary objective of this trial is to observe the Multiple Sclerosis (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. The secondary objectives are: To investigate changes in fatigue, capacity for work, Health Related Quality of Life (HRQol), sleepiness, cognitive impairment, physically activity induced exhaustion, speed of walking, status of MS disease progression and amount of walking at different times points after initiation of Tysabri treatment in participants diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS). Changes in fatigue are measured at 3, 6 and 9 months, whereas changes in capacity for work, HRQoL, sleepiness, cognitive impairment, physical activity induced exhaustion, speed of walking, status of MS disease progression and amount of walking are measured at 6 and 12 months. To investigate correlation between fatigue and cognitive impairment, depression and physically activity induced exhaustion and status of MS disease progression in participants at baseline, 6 and 12 month of treatment with Tysabri and to document any changes in fatigue related medication.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2009

Typical duration for all trials

Geographic Reach
4 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2011

Completed
Last Updated

November 8, 2018

Status Verified

November 1, 2018

Enrollment Period

2.3 years

First QC Date

April 17, 2009

Last Update Submit

November 6, 2018

Conditions

Relapsing-Remitting Multiple SclerosisFatigue

Outcome Measures

Primary Outcomes (1)

  • 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.

    A fatigue scale for motor and cognitive functions (FSMC) has been developed and validated by Penner et al. FSMC differentiates between motor and cognitive fatigue and is less susceptible to confounding by depression. Thus, FSMC is more specific in measuring MS-related fatigue.

    0 month and 12 months

Secondary Outcomes (12)

  • Changes in fatigue after initiation of Tysabri treatment

    3 months, 6 months, 9 months

  • Change in capacity for work (capacity for work questionnaire (CWQ)) at different points after initiation of Tysabri treatment

    0, 6 months, 12 months

  • Change in health-related-quality of life (HRQ0L) (short form-12 questions (SF-12)) at different points after initiation of Tysabri treatment

    0, 6 months, 12 months

  • Change in Sleepiness (Epworth sleepiness scale (ESS)) at different points after initiation of Tysabri treatment

    0, 6 months, 12 months

  • Change in cognitive impairment (the paced auditory serial addition test (PASAT) and symbol digit modalities test (SDMT)) at different points after initiation of Tysabri treatment

    0, 6 months, 12 months

  • +7 more secondary outcomes

Study Arms (1)

Natalizumab

Participants with MS treated with Tysabri over 12 months

Other: Natalizumab

Interventions

NatalizumabOTHER

Participants treated with Tysabri

Also known as: BG00002, Tysabri
Natalizumab

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects diagnosed with Relapsing Remitting Multiple Sclerosis initiating treatment with Tysabri

You may qualify if:

  • Tysabri prescribed according to national guidelines but not yet started treatment
  • Signed informed consent form
  • FSMC sum score above \> 43 at baseline (mild fatigue)

You may not qualify if:

  • FSMC sum score below 43 at baseline
  • History of treatment with Tysabri
  • EDSS \> 6 at baseline
  • Amphetamine as medication
  • Major depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Research Site

Graz, Austria

Location

Research Site

Innsbruck, Austria

Location

Research Site

Salzburg, Austria

Location

Research Site

Vienna, Austria

Location

Research Site

Villach, Austria

Location

Research Site

Aarhus, Denmark

Location

Research Site

Copenhagen, Denmark

Location

Research Site

Odense, Denmark

Location

Research Site

Bergen, Norway

Location

Research Site

Bodø, Norway

Location

Research Site

Drammen, Norway

Location

Research Site

Førde, Norway

Location

Research Site

Lillehammer, Norway

Location

Research Site

Molde, Norway

Location

Research Site

Oslo, Norway

Location

Research Site

Danderyd, Sweden

Location

Research Site

Gothenburg, Sweden

Location

Research Site

Helsingborg, Sweden

Location

Research Site

Jönköping, Sweden

Location

Research Site

Karlstad, Sweden

Location

Research Site

Lund, Sweden

Location

Research Site

Malmo, Sweden

Location

Research Site

Norrköping, Sweden

Location

Research Site

Örebro, Sweden

Location

Research Site

Stockholm, Sweden

Location

Research Site

Trollhättan, Sweden

Location

Research Site

Umeå, Sweden

Location

Related Publications (3)

  • Wickstrom A, Dahle C, Vrethem M, Svenningsson A. Reduced sick leave in multiple sclerosis after one year of natalizumab treatment. A prospective ad hoc analysis of the TYNERGY trial. Mult Scler. 2014 Jul;20(8):1095-101. doi: 10.1177/1352458513517590. Epub 2013 Dec 30.

    PMID: 24378984RESULT

  • Svenningsson A, Falk E, Celius EG, Fuchs S, Schreiber K, Berko 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.

    PMID: 23555589RESULT

  • Penner IK, Sivertsdotter EC, Celius EG, Fuchs S, Schreiber K, Berko S, Svenningsson A; TYNERGY trial investigators. Improvement in Fatigue during Natalizumab Treatment is Linked to Improvement in Depression and Day-Time Sleepiness. Front Neurol. 2015 Feb 23;6:18. doi: 10.3389/fneur.2015.00018. eCollection 2015.

    PMID: 25755648RESULT

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingFatigue

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2009

First Posted

April 20, 2009

Study Start

March 23, 2009

Primary Completion

June 30, 2011

Study Completion

June 30, 2011

Last Updated

November 8, 2018

Record last verified: 2018-11

Locations

NO(7)AU(5)DK(3)SE(12)