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Effects of Tysabri (BG00002) Over 12 Months on MS Related Fatigue in Participants With RRMS

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing-Remitting Multiple Sclerosis; Fatigue

Intervention: Natalizumab (Other)

Phase: N/A

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: 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.

Secondary outcome:

Changes in fatigue after initiation of Tysabri treatment

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

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

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

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

Change in depression (Center for epidemiologic studies depression scale (CES-D)) at different points after initiation of Tysabri treatment

Change in Physical activity induced exhaustion (Borg scale CR10 (BS-CR10)) at different points after initiation of Tysabri treatment

Change in speed of walking (6MWT) at different points after initiation of Tysabri treatment

Change in status of MS disease progression (expanded disability status scale (EDSS)) at different points after initiation of Tysabri treatment

Change in amount of walking (step counter) at different points after initiation of Tysabri treatment

To investigate correlation between fatigue and cognitive impairment, depression and physically activity induced exhaustion and status of MS disease progression

To document any changes in fatigue related medication

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Key Inclusion Criteria:

- Tysabri prescribed according to national guidelines but not yet started treatment

- Signed informed consent form

- FSMC sum score above > 43 at baseline (mild fatigue)

Key Exclusion Criteria:

- FSMC sum score below 43 at baseline

- History of treatment with Tysabri

- EDSS > 6 at baseline

- Amphetamine as medication

- Major depression

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Locations and Contacts

University of Chicago, Chicago, Illinois 60637, United States
Additional Information

Starting date: March 2009
Last updated: July 9, 2015

Page last updated: August 23, 2015

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