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

NCT01591551 | Completed Phase 4

• 1 other identifier: US-TYS-11-10221
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (1)

• Change in parameters of sleep as measured by polysomnography and multi-sleep latency test over 6 months of Natalizumab treatment.

  Baseline and 6 months

Secondary Outcomes (2)

• 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.

  Baseline and 6 months

Study Arms (1)

Natalizumab (Tysabri) naive

OTHER

Patients who are newly prescribed Natalizumab (TYSABRI®), but have not received their first infusion, will be invited to participate.

Drug: Natalizumab (Tysabri)

Interventions

Natalizumab (Tysabri) DRUG

300 mg IV every 4 weeks

Natalizumab (Tysabri) naive

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe cognitive impairment
• Coexisting severe medical condition
• Inability to speak English or read
• Inability to give valid informed consent.

Sponsors & Collaborators

• Cornerstone Health Care, PA: lead
• Biogen: collaborator

Study Sites (3)

South Shore Neurologic Associates

Patchogue, New York, 11772, United States

Location

Cornerstone Neurology

High Point, North Carolina, 27262, United States

Location

Providence Brain Institute

Portland, Oregon, 97225, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Richard A Sater, MD, PhD

  Cornerstone Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2012
• First Posted: May 4, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 29, 2014

Record last verified: 2014-01

Locations

US (3)