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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-08-31

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.

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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.

Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Natalizumab (Tysabri) naive

Patients who are newly prescribed Natalizumab (TYSABRI®), but have not received their first infusion, will be invited to participate.

Group Type OTHER

Natalizumab (Tysabri)

Intervention Type DRUG

300 mg IV every 4 weeks

Interventions

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Natalizumab (Tysabri)

300 mg IV every 4 weeks

Intervention Type DRUG

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