Evaluation of Natalizumab for thE Relief of MS Associated FatiGue (NCT00464074) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Natalizumab for thE Relief of MS Associated FatiGue
United States, Puerto Rico89 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analog Scale for Fatigue (VAS-F)
Timeframe: at three months after initiating treatment with TYSABRI®
. 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.