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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591551
• Other study ID #: US-TYS-11-10221
• Status: Completed
• Phase: Phase 4
• First received: April 22, 2012
• Last updated: January 28, 2014
• Start date: March 2012
• Est. completion date: August 2013

Study information

• Verified date: January 2014
• Source: Cornerstone Health Care, PA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Natalizumab (Tysabri)
300 mg IV every 4 weeks

Locations

Country	Name	City	State
United States	Cornerstone Neurology	High Point	North Carolina
United States	South Shore Neurologic Associates	Patchogue	New York
United States	Providence Brain Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Cornerstone Health Care, PA	Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in parameters of sleep as measured by polysomnography and multi-sleep latency test over 6 months of Natalizumab treatment.		Baseline and 6 months	No
Secondary	Change in neurocognition parameters over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency.		Baseline and 6 months	No
Secondary	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	No