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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Drug: Natalizumab (Tysabri)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Natalizumab (Tysabri) naive<br>Patients who are newly prescribed Natalizumab (TYSABRI®), but have not received their first infusion, will be invited to participate. | Drug: Natalizumab (Tysabri)<br>* 300 mg IV every 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in parameters of sleep as measured by polysomnography and multi-sleep latency test over 6 months of Natalizumab treatment. |  | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neurocognition parameters over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency. |  | 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. |  | Baseline and 6 months |