NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cornerstone Health Care, PA
• Collaborator: Biogen
• Treatments: Natalizumab

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.