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| Name | Class |
|---|---|
| Biogen | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natalizumab (Tysabri) naive | Other | Patients who are newly prescribed Natalizumab (TYSABRI®), but have not received their first infusion, will be invited to participate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natalizumab (Tysabri) | Drug | 300 mg IV every 4 weeks |
|
| Measure | Description | 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 |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard A Sater, MD, PhD | Cornerstone Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Shore Neurologic Associates | Patchogue | New York | 11772 | United States | ||
| Cornerstone Neurology |
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| Baseline and 6 months |
| High Point |
| North Carolina |
| 27262 |
| United States |
| Providence Brain Institute | Portland | Oregon | 97225 | United States |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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