CompletedPhase 4Other

Natalizumab Temporary Discontinuation Study

NCT ID

NCT02775110

Target Enrollment

50 participants

Start Date

2012-11

Est. Completion

2014-03

About This Study

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.

Conditions Studied

Multiple Sclerosis

Interventions

•Natalizumab discontinuation

Eligibility

Age:18 Years - 65 Years

Healthy Volunteers:No

View full eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Study Locations (2)

Buffalo Neuroimaging Analysis Center

Buffalo, New York, United States

Jacobs Neurological Institute