Evaluation of Natalizumab for thE Relief of MS Associated FatiGue

Completed

Conditions studied: Multiple Sclerosis

In brief

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

Key facts

Study ID

NCT00464074

Run by

Biogen

People needed

89

Starts

2007-08-01

Expected to finish

2010-07-31

Last updated by the study team

2023-08-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Patients not enrolled in the TOUCH prescribing program.
• History or presence of progressive multifocal leukoencephalopathy (PML).
• Diagnosis of primary progressive MS (PPMS) or secondary progressive MS (SPMS) without relapses.
• Immunocompromised in the judgment of the investigator.
• Allergy or hypersensitivity to TYSABRI®.
• 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®.
• Women pregnant, breast feeding, or planning to become pregnant and women who are not postmenopausal or surgically sterile, and unwilling to practice contraception.
• A baseline average VAS-F score of < 60.
• Problems with upper extremity dexterity that could preclude usage of a computer mouse.
• With educational completion below 8th grade school equivalent or non-fluent in English.
• Any other reason, in the opinion of both the Investigator and/or Sponsor, the patient is determined not suitable for study participation.

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — Fresno, California, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Idaho Falls, Idaho, United States
• Research Site — Evanston, Illinois, United States
• Research Site — Lake Barrington, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — West Des Moines, Iowa, United States
• Research Site — Lexington, Kentucky, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Lexington, Massachusetts, United States
• Research Site — Farmington Hills, Michigan, United States
• Research Site — Buffalo, New York, United States
• Research Site — New York, New York, United States
• Research Site — Patchogue, New York, United States
• Research Site — Chapel Hill, North Carolina, United States
• Research Site — High Point, North Carolina, United States
• Research Site — Raleigh, North Carolina, United States
• Research Site — Portland, Oregon, United States
• Research Site — Anderson, South Carolina, United States
• Research Site — Franklin, Tennessee, United States
• Research Site — Knoxville, Tennessee, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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