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

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
Cornerstone Health Care, PA
ClinicalTrials.gov Identifier:
NCT01591551
First received: April 22, 2012
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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 ] [ Designated as safety issue: No ]

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 ] [ 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 ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01591551

Locations
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
Biogen Idec
Investigators
Principal Investigator: Richard A Sater, MD, PhD Cornerstone Healthcare
  More Information

No publications provided

Responsible Party: Cornerstone Health Care, PA
ClinicalTrials.gov Identifier: NCT01591551     History of Changes
Other Study ID Numbers: US-TYS-11-10221
Study First Received: April 22, 2012
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014