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Clinical Trial Summary

The purpose of this study is to assess the impact of Natalizumab (Tysabri) therapy on sleep efficiency, total sleep time and sleep latency, in Multiple Sclerosis (MS) patients receiving Natalizumab for 6 months relative to baseline.


Clinical Trial Description

Natalizumab has been shown to positively impact fatigue and cognition. The mechanism by which this occurs is unknown. Change in quality of sleep is one possible etiology of these findings. This study will help to elucidate the mechanisms that lead to reduced fatigue/sleepiness and less cognitive dysfunction in MS patients who go on Natalizumab therapy. Understanding these factors may help neurologists better differentiate between the different therapeutic options for MS and how they may impact symptoms that negatively affect quality of life. ;


Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT01591551
Study type Interventional
Source Cornerstone Health Care, PA
Contact
Status Completed
Phase Phase 4
Start date March 2012
Completion date August 2013

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