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NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Relapsing Forms of Multiple Sclerosis Experiencing Fatigue or Sleepiness
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.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
South Shore Neurologic Associates
Patchogue, New York, United States
Cornerstone Neurology
High Point, North Carolina, United States
Providence Brain Institute
Portland, Oregon, United States
Start Date
March 1, 2012
Primary Completion Date
August 1, 2013
Completion Date
August 1, 2013
Last Updated
January 29, 2014
37
ACTUAL participants
Natalizumab (Tysabri)
DRUG
Lead Sponsor
Cornerstone Health Care, PA
Collaborators
NCT05359653
NCT06390930
Data Source & Attribution
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