Status:
COMPLETED
Evaluation of Natalizumab for thE Relief of MS Associated FatiGue
Lead Sponsor:
Biogen
Collaborating Sponsors:
Elan Pharmaceuticals
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
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 im...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2010
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00464074
Start Date
August 1 2007
End Date
July 31 2010
Last Update
August 22 2023
Active Locations (31)
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1
Research Site
Phoenix, Arizona, United States, 85006
2
Research Site
Fresno, California, United States, 93720
3
Research Site
Atlanta, Georgia, United States, 30327
4
Research Site
Idaho Falls, Idaho, United States, 83404