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NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness

This study is currently recruiting participants.
Verified May 2012 by Cornerstone Health Care, PA
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
Cornerstone Health Care, PA
ClinicalTrials.gov Identifier:
NCT01591551
First received: April 22, 2012
Last updated: May 2, 2012
Last verified: May 2012
History of Changes

April 22, 2012
May 2, 2012
March 2012
June 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01591551 on ClinicalTrials.gov Archive Site
  • Change in neurocognition parameters over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness
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.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Multiple Sclerosis, Relapsing-Remitting
Drug: Natalizumab (Tysabri)
300 mg IV every 4 weeks
Natalizumab (Tysabri) naive
Patients who are newly prescribed Natalizumab (TYSABRI®), but have not received their first infusion, will be invited to participate.
Intervention: Drug: Natalizumab (Tysabri)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
July 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Relapsing form of multiple sclerosis
  • Able to give informed consent and committed to follow the protocol
  • EDSS from 0 to 6.0
  • Epworth Sleepiness Scale > 9 or Modified Fatigue Impact Scale > 30 or Fatigue Severity Scale > 4
  • Age range of 18 - 65 years of age
  • Naïve to Natalizumab
  • Enrolled in the TOUCH program

Exclusion Criteria:

  • Severe cognitive impairment
  • Coexisting severe medical condition
  • Inability to speak English or read
  • Inability to give valid informed consent.
Both
18 Years to 65 Years
No
Not Provided
United States
 
NCT01591551
US-TYS-11-10221
No
Cornerstone Health Care, PA
Cornerstone Health Care, PA
Biogen Idec
Principal Investigator: Richard A Sater, MD, PhD Cornerstone Healthcare
Cornerstone Health Care, PA
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP