CompletedNot Applicable

Evaluation of Natalizumab for thE Relief of MS Associated FatiGue

United States89 participantsStarted 2007-08-01

Plain-language summary

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

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Visual Analog Scale for Fatigue (VAS-F)

Timeframe: at three months after initiating treatment with TYSABRI®

NCT IDNCT00464074

SponsorBiogen

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2010-07-31

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.