A Phase 4 interventional study of Natalizumab (Tysabri) in Multiple Sclerosis, Relapsing-Remitting, sponsored by Cornerstone Health Care, PA. Completed at 3 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-01-29.
Sponsored by Cornerstone Health Care, PA · Phase 4, Interventional, and Supportive care
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 37 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Cornerstone Health Care, PA is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who are newly prescribed Natalizumab (TYSABRI®), but have not received their first infusion, will be invited to participate.
Drug: Natalizumab (Tysabri)
300 mg IV every 4 weeks
Change in parameters of sleep as measured by polysomnography and multi-sleep latency test over 6 months of Natalizumab treatment.
Time frame: Baseline and 6 months
Change in neurocognition parameters over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency.
Time frame: Baseline and 6 months
Change in subjective measures of fatigue, sleepiness and mood over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency.
Time frame: Baseline and 6 months
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cornerstone Health Care, PA