NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness
This study is currently recruiting participants.
Verified May 2012 by Cornerstone Health Care, PA
Sponsor:
Cornerstone Health Care, PA
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
Cornerstone Health Care, PA
ClinicalTrials.gov Identifier:
NCT01591551
First received: April 22, 2012
Last updated: May 2, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis, Relapsing-Remitting |
Drug: Natalizumab (Tysabri) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Relapsing Forms of Multiple Sclerosis Experiencing Fatigue or Sleepiness |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
Drug Information available for:
Natalizumab
U.S. FDA Resources
Further study details as provided by Cornerstone Health Care, PA:
Primary Outcome Measures:
- Change in parameters of sleep as measured by polysomnography and multi-sleep latency test over 6 months of Natalizumab treatment. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in neurocognition parameters over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
- Change in subjective measures of fatigue, sleepiness and mood over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 32 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Natalizumab (Tysabri) naive
Patients who are newly prescribed Natalizumab (TYSABRI®), but have not received their first infusion, will be invited to participate.
|
Drug: Natalizumab (Tysabri)
300 mg IV every 4 weeks
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591551
Locations
| United States, New York | |
| South Shore Neurologic Associates | Active, not recruiting |
| Patchogue, New York, United States, 11772 | |
| United States, North Carolina | |
| Cornerstone Neurology | Recruiting |
| High Point, North Carolina, United States, 27262 | |
| Contact: Pamela A Sater, PA-C 336-802-2080 | |
| Principal Investigator: Richard A Sater, MD, PhD | |
| Sub-Investigator: Pamela A Sater, PA-C | |
| United States, Oregon | |
| Providence Brain Institute | Active, not recruiting |
| Portland, Oregon, United States, 97225 | |
| United States, Tennessee | |
| Hope Neurology | Active, not recruiting |
| Knoxville, Tennessee, United States, 37916 | |
Sponsors and Collaborators
Cornerstone Health Care, PA
Biogen Idec
Investigators
| Principal Investigator: | Richard A Sater, MD, PhD | Cornerstone Healthcare |
More Information
No publications provided
| Responsible Party: | Cornerstone Health Care, PA |
| ClinicalTrials.gov Identifier: | NCT01591551 History of Changes |
| Other Study ID Numbers: | US-TYS-11-10221 |
| Study First Received: | April 22, 2012 |
| Last Updated: | May 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013