Multiple Sclerosis Clinical Trial
NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness
Summary
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.
Full 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 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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 3 Locations for this study
Patchogue New York, 11772, United States
High Point North Carolina, 27262, United States
Portland Oregon, 97225, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.