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

Phase 4

Completed

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: Natalizumab (Tysabri)

• Registration Number: NCT01591551
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-22
• Study First Submitted QC: 2012-05-02
• Study First Posted: 2012-05-04
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-28
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

South Shore Neurologic Associates; 🇺🇸 Patchogue, New York, United States

Cornerstone Neurology; 🇺🇸 High Point, North Carolina, United States

Providence Brain Institute; 🇺🇸 Portland, Oregon, United States