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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01591551

Enrollment

Registered

2012-05-04

Start date

2012-03-31

Completion date

2013-08-31

Last updated

2014-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

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.

Interventions

DRUGNatalizumab (Tysabri)

300 mg IV every 4 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026