Multiple Sclerosis Clinical Trial

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

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.

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Full 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.

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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.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

37

Study ID:

NCT01591551

Recruitment Status:

Completed

Sponsor:

Cornerstone Health Care, PA

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There are 3 Locations for this study

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South Shore Neurologic Associates
Patchogue New York, 11772, United States
Cornerstone Neurology
High Point North Carolina, 27262, United States
Providence Brain Institute
Portland Oregon, 97225, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

37

Study ID:

NCT01591551

Recruitment Status:

Completed

Sponsor:


Cornerstone Health Care, PA

How clear is this clinincal trial information?

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