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DSIP

Emideltide, DSIP nonapeptide, Delta sleep-inducing peptide

Quick Stats
Studies 458
Trials 82
Completed OBSERVATIONAL NCT00884481

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

Name: Natalizumab
Type: OTHER
Description: Participants treated with Tysabri

Primary Outcomes

Measure: 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.
TimeFrame: 0 month and 12 months
Description: 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.

Trial Information

NCT ID

NCT00884481

Status

Completed

Study Type

OBSERVATIONAL

Sponsor

Biogen

Last Updated

December 15, 2025