View Clinical Trial (Medical Research Study)
NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Relapsing Forms of Multiple Sclerosis Experiencing Fatigue or Sleepiness
| City: |
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High Point |
| State: |
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North Carolina |
| Zip Code: |
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27262 |
| Conditions: |
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Multiple Sclerosis, Relapsing-Remitting |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT01591551 |
| Primary Contact: |
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Principal Investigator
Richard A Sater, MD, PhD
Cornerstone Healthcare
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| Backup Contact: |
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N/A |
| Location Contact: |
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High Point, North Carolina 27262
United States
Pamela A Sater, PA-C
Phone: 336-802-2080
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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