Natalizumab Temporary Discontinuation Study

Completed · Phase 4

Conditions studied: Multiple Sclerosis

In brief

This study evaluates the discontinuation of natalizumab either immediately or tapered off in the treatment of multiple sclerosis. Half of the fifty (50) participants will discontinue natalizumab immediately and the other half will taper off the drug, having two additional infusions, one at six weeks- and one at eight weeks-post discontinuation.

Key facts

Study ID

NCT02775110

Run by

University at Buffalo

People needed

50

Starts

2012-11-01

Expected to finish

2014-03-01

Last updated by the study team

2016-05-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient with relapsing-remitting or relapsing-progressive (relapsing-remitting with incomplete recovery and secondary progressive with superimposed relapses) MS according to the McDonald criteria who have been on natalizumab therapy for at least 12 months
• Age 18-65
• Have EDSS scores less than or equal to 7.0
• Positive John Cunningham (JC) virus antibody results at screening
• Signed informed consent
• None of the exclusion criteria

You may not qualify if…

• Patients not willing or able to personally provide informed consent (subjects with cognitive impairment that effects the ability to provide informed consent for participation)
• Patients with active disease per clinical and MRI evaluation at baseline
• Patients with renal disease that precludes having an MRI with gadolinium contrast

Where it is running

• Buffalo Neuroimaging Analysis Center — Buffalo, New York, United States
• Jacobs Neurological Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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