NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness
What it found
We found no results in the registry or in papers.
This trial finished 13 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
What it measured
Main measures
Change in parameters of sleep as measured by polysomnography and multi-sleep latency test over 6 months of Natalizumab treatment.
Baseline and 6 months
Myelin repairMood and sleep
Other measures (2)
Change in neurocognition parameters over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency.
Baseline and 6 months
Thinking and memoryMood and sleepChange in subjective measures of fatigue, sleepiness and mood over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency.
Baseline and 6 months
FatigueMood and sleep
Who could take part
Relapsing MS · 18 to 65
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Mar 2012
Main results due
Aug 2013
Finished
Aug 2013
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