Mutiple sclerosis related fatigue in subjects with relapsing remitting multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10016256 Term: Fatigue
Conditions
Interventions
Trade Name: Tysabri
Pharmaceutical Form: Intravenous infusion
Sponsors
BiogenIdec A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years and age = 65 years at screening • Subjects who have been prescribed Tysabri® according to national guidelines but not yet started treatment • Signed informed consent form (ICF) • FSMC sum score = 43 at baseline (mild fatigue) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • FSMC sum score < 43 at baseline • History of treatment with Tysabri® • EDSS = 6 at baseline • Amphetamine as medication • Major depression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to investigate the MS related fatigue during treat-ment with Tysabri® as measured by changes in the fatigue scale for motor and cognitive functions (FMSC) over the course of 12 months.;Secondary Objective: • to investigate changes in fatigue, capacity for work, HRQoL, sleepiness, cognitive impairment, physically activity induced exhaustion, speed of walking, status of MS disease progression and amount of walking at different time points after initiation of Tysabri® treatment in subjects diagnosed with 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 subjects at baseline, 6 and 12 month of treatment with Tysabri®. • to document any changes in fatigue related medication. ;Primary end point(s): The primary endpoint is fatigue associated with MS (FSMC) measured at 0 and 12 months after initiating treatment with Tysabri®. | — |
Countries
Sweden
Outcome results
None listed