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

Information source: Cornerstone Health Care, PA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting

Intervention: Natalizumab (Tysabri) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Cornerstone Health Care, PA

Official(s) and/or principal investigator(s):
Richard A Sater, MD, PhD, Principal Investigator, Affiliation: Cornerstone Healthcare

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.

Clinical Details

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

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Change in parameters of sleep as measured by polysomnography and multi-sleep latency test over 6 months of Natalizumab treatment.

Secondary outcome:

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

Change in subjective measures of fatigue, sleepiness and mood over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

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

Additional Information

Starting date: March 2012
Last updated: January 28, 2014

Page last updated: August 23, 2015

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