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.
Drug: Natalizumab (Tysabri)
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Locations near you
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Full eligibility criteria for NCT01591551
Ages eligible for Study
18 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
Severe cognitive impairment
Coexisting severe medical condition
Inability to speak English or read
Inability to give valid informed consent.
All locations for NCT01591551
United States (4)
South Shore Neurologic Associates
Patchogue, New York, United States, 11772
High Point, North Carolina, United States, 27262
Providence Brain Institute
Portland, Oregon, United States, 97225
Knoxville, Tennessee, United States, 37916
View full eligibility
Tris trial is registered with FDA with number: NCT01591551. The sponsor of the trial is Cornerstone Health Care, PA and it is looking for 37 volunteers for the current phase.
Official trial title: NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Relapsing Forms of Multiple Sclerosis Experiencing Fatigue or Sleepiness
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