Back to resultsNAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness
Primary Purpose
Multiple Sclerosis, Relapsing-Remitting
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Natalizumab (Tysabri)
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Sclerosis, Relapsing-Remitting
Eligibility 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.
Sites / Locations
- South Shore Neurologic Associates
- Cornerstone Neurology
- Providence Brain Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Natalizumab (Tysabri) naive
Arm Description
Patients who are newly prescribed Natalizumab (TYSABRI®), but have not received their first infusion, will be invited to participate.
Outcomes
Primary Outcome Measures
Change in parameters of sleep as measured by polysomnography and multi-sleep latency test over 6 months of Natalizumab treatment.
Secondary Outcome Measures
Change in neurocognition parameters over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency.
Change in subjective measures of fatigue, sleepiness and mood over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency.
Full Information
NCT ID
NCT01591551
First Posted
April 22, 2012
Last Updated
January 28, 2014
Sponsor
Cornerstone Health Care, PA
Collaborators
Biogen
1. Study Identification
Unique Protocol Identification Number
NCT01591551
Brief Title
NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness
Official Title
NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Relapsing Forms of Multiple Sclerosis Experiencing Fatigue or Sleepiness
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornerstone Health Care, PA
Collaborators
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Natalizumab (Tysabri) naive
Arm Type
Other
Arm Description
Patients who are newly prescribed Natalizumab (TYSABRI®), but have not received their first infusion, will be invited to participate.
Intervention Type
Drug
Intervention Name(s)
Natalizumab (Tysabri)
Intervention Description
300 mg IV every 4 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in neurocognition parameters over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency.
Time Frame
Baseline and 6 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A Sater, MD, PhD
Organizational Affiliation
Cornerstone Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Shore Neurologic Associates
City
Patchogue
State/Province
New York
ZIP/Postal Code
11772
Country
United States
Facility Name
Cornerstone Neurology
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Providence Brain Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
12. IPD Sharing Statement
Learn more about this trial
NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness
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