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

Completed · Phase 4

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

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.

Key facts

Study ID

NCT01591551

Run by

Cornerstone Health Care, PA

People needed

37

Starts

2012-03-01

Expected to finish

2013-08-01

Last updated by the study team

2014-01-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Severe cognitive impairment
• Coexisting severe medical condition
• Inability to speak English or read
• Inability to give valid informed consent.

Where it is running

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

Full record on ClinicalTrials.gov

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