Clinical trial NCT00464074: Evaluation of Natalizumab for thE Relief of MS Associated FatiGue
Official title: Multi-center, Open-Label Study to Evaluate the Effects of Natalizumab Treatment on Fatigue and Cognition in Subjects With Relapsing Forms of MS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: fatigue
Tysabri
cognition
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Elan Pharmaceuticals
First posted: 2007-04-20
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: multicenter clinic patients

Brief summary: This study aims to study the effects of TYSABRI® treatment on fatigue and cognition in patients with relapsing forms of MS.

Detailed description: TYSABRI® treatment has already demonstrated significant improvement in the quality of life (QoL) of patients with MS. In particular, TYSABRI® add-on treatment to interferon beta-1a has demonstrated improvement in fatigue as measured by the Modified Fatigue Impact Scale (MFIS). Both patients and neurologists report that patients have experienced significant improvements in fatigue shortly after initiating TYSABRI® treatment. Fatigue is both a common and a disabling symptom of MS. Further, there is evidence that fatigue contributes to cognitive difficulties in patients with MS. This study aims to study the effects of TYSABRI® treatment on fatigue and cognition in patients with relapsing forms of MS.

The primary objective of this study is to determine the effects of TYSABRI® treatment on fatigue in subjects with relapsing forms of MS as measured by changes in patient-reported Visual Analog Scale for Fatigue (VAS-F).

Primary endpoint is the change in the following:

1. Visual Analog Scale for Fatigue (VAS-F) at three months after initiating treatment with TYSABRI®.

Secondary objectives are to measure changes in patient-reported Modified Fatigue Impact Scale (MFIS) and Fatigue Severity Scale (FSS).

Secondary endpoints are changes in the following:

1. Modified Fatigue Impact Scale (MFIS)
2. Fatigue Severity Scale (FSS)

The tertiary objective of this study is to explore for any effects of TYSABRI® treatment on cognition by assessing changes in the Automated Neuropsychology Assessment Metrics (ANAM).

Tertiary endpoints are changes in the Automated Neuropsychology Assessment Metrics (ANAM) consisting of:

* Traditional Continuous Performance Test
* Running Memory Continuous Performance Test
* Simple Response Time
* Procedural Response Time
* Coding Substitution
* Mathematics
* Logical Relations
* Matching-to-Sample
* Stanford Sleepiness Scale

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of relapsing forms of MS.
2. Patients having an inadequate response to or unable to tolerate alternate MS therapies.
3. Patient must be enrolled in the TOUCH prescribing program.
4. Recent MRI as part of the TOUCH prescribing program.
5. Patient must be between 18 and 55 years of age, inclusive.
6. EDSS between 0 and 5.5, inclusive.
7. Able to provide written informed consent.
8. Capable of completing the fatigue (MFIS, FSS, and VAS-F) and cognition (ANAM) sessions.
9. A baseline VAS-F average score of \> 60.
10. Patient must be naÃƒ-ve to TYSABRI® treatment.

Exclusion Criteria:

1. Patients not enrolled in the TOUCH prescribing program.
2. History or presence of progressive multifocal leukoencephalopathy (PML).
3. Diagnosis of primary progressive MS (PPMS) or secondary progressive MS (SPMS) without relapses.
4. Immunocompromised in the judgment of the investigator.
5. Allergy or hypersensitivity to TYSABRI®.
6. Prior history or current presence of a clinically significant medical illness or laboratory abnormality, including any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, and/or other major disease, that, in the opinion of the investigator, would preclude the administration of TYSABRI®.
7. Women pregnant, breast feeding, or planning to become pregnant and women who are not postmenopausal or surgically sterile, and unwilling to practice contraception.
8. A baseline average VAS-F score of \< 60.
9. Problems with upper extremity dexterity that could preclude usage of a computer mouse.
10. With educational completion below 8th grade school equivalent or non-fluent in English.
11. Any other reason, in the opinion of both the Investigator and/or Sponsor, the patient is determined not suitable for study participation.

Primary outcomes:
measure: Visual Analog Scale for Fatigue (VAS-F)
timeFrame: at three months after initiating treatment with TYSABRI®
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Fresno
country: United States
facility: Research Site
state: California
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Idaho Falls
country: United States
facility: Research Site
state: Idaho
city: Evanston
country: United States
facility: Research Site
state: Illinois
city: Lake Barrington
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: West Des Moines
country: United States
facility: Research Site
state: Iowa
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Lexington
country: United States
facility: Research Site
state: Massachusetts
city: Farmington Hills
country: United States
facility: Research Site
state: Michigan
city: Buffalo
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Patchogue
country: United States
facility: Research Site
state: New York
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: High Point
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Anderson
country: United States
facility: Research Site
state: South Carolina
city: Franklin
country: United States
facility: Research Site
state: Tennessee
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Charleston
country: United States
facility: Research Site
state: West Virginia
city: Waukesha
country: United States
facility: Research Site
state: Wisconsin
city: Guaynabo
country: Puerto Rico
facility: Research Site
Study officials:
References: