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Completed

NCT Number: NCT01591551

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

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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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

South Shore Neurologic Associates, Patchogue, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Natalizumab (Tysabri)

Drug

300 mg IV every 4 weeks

Primary outcomes

  1. 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 outcomes

  1. Change in neurocognition parameters over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency.

    Time frame: Baseline and 6 months

  2. 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

Sponsors and collaborators

Lead sponsor

Cornerstone Health Care, PA

Other

Collaborators

  • Biogen

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 4, 2012
Registry last updated
Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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