Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Cornerstone Health Care, PA Identifier:
First received: April 22, 2012
Last updated: January 28, 2014
Last verified: January 2014
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.

Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Drug: Natalizumab (Tysabri)
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Relapsing Forms of Multiple Sclerosis Experiencing Fatigue or Sleepiness

Resource links provided by NLM:

Further study details as provided by Cornerstone Health Care, PA:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 37
Study Start Date: March 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Natalizumab (Tysabri) naive
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

Detailed 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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01591551

United States, New York
South Shore Neurologic Associates
Patchogue, New York, United States, 11772
United States, North Carolina
Cornerstone Neurology
High Point, North Carolina, United States, 27262
United States, Oregon
Providence Brain Institute
Portland, Oregon, United States, 97225
Sponsors and Collaborators
Cornerstone Health Care, PA
Principal Investigator: Richard A Sater, MD, PhD Cornerstone Healthcare
  More Information

Responsible Party: Cornerstone Health Care, PA Identifier: NCT01591551     History of Changes
Other Study ID Numbers: US-TYS-11-10221
Study First Received: April 22, 2012
Last Updated: January 28, 2014

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
Immunologic Factors
Physiological Effects of Drugs processed this record on May 22, 2017