Effects of Tysabri (BG00002) Over 12 Months on MS Related Fatigue in Participants With RRMS
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Neurology, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | March 2009 |
| End Date: | June 2011 |
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
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.
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.
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
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