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

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ClinicalTrials.gov Identifier: NCT01591551
Recruitment Status : Completed
First Posted : May 4, 2012
Last Update Posted : January 29, 2014
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Cornerstone Health Care, PA

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: Natalizumab (Tysabri) Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. Change in neurocognition parameters over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency. [ Time Frame: Baseline and 6 months ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Investigators
Principal Investigator: Richard A Sater, MD, PhD Cornerstone Healthcare

Responsible Party: Cornerstone Health Care, PA
ClinicalTrials.gov Identifier: NCT01591551     History of Changes
Other Study ID Numbers: US-TYS-11-10221
First Posted: May 4, 2012    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Fatigue
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
Natalizumab
Immunologic Factors
Physiological Effects of Drugs