The purpose of this study is to determine the safety and tolerability of ELND002 in patients with relapsing forms of secondary progressive multiple sclerosis (SPMS) or relapsing-remitting multiple sclerosis (RRMS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Research Site
Berkeley, California, United States
Research Site
Fresno, California, United States
To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT) and determination of the maximum tolerated dose (MTD) in patients with multiple sclerosis (MS).
Time frame: 12 weeks
Assessment of PK and PD measures of ELND002 (including but not limited to Cmax, Tmax, T1/2, AUC)
Measurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM.
Time frame: 12 weeks
Assessment of the cumulative number and volume of Gd-enhancing T1-weighed MRI brain lesions
Time frame: 12 weeks
Reduction in rate of clinical relapses.
Time frame: 12 weeks
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Research Site
Newport Beach, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Tampa, Florida, United States
Research Site
Vero Beach, Florida, United States
Research Site
Northbrook, Illinois, United States
Research Site
Farmington Hills, Michigan, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Albuquerque, New Mexico, United States
...and 10 more locations