This is a phase 2, randomized, double-blind, parallel-group, single dose study to evaluate the safety and efficacy of 2 dose levels of REGN475 compared with placebo in patients with sciatic pain. Enrollment of approximately 50 patients in each of the 3 treatment arms is expected at up to 35 US sites, for a total enrollment of approximately 150 patients. Patients will receive 1 injection under the skin of either active or placebo REGN475, and be followed over 10 visits for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
159
Sciatic pain between baseline and end of week 4
Time frame: 4 weeks
Additional measures of sciatic pain.
Time frame: 6 weeks
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Regeneron Investigational Site
Birmingham, Alabama, United States
Regeneron Investigational Site
Mobile, Alabama, United States
Regeneron Investigational Site
Peoria, Arizona, United States
Regeneron Investigational Site
Anaheim, California, United States
Regeneron Investigational Site
Beverly Hills, California, United States
Regeneron Investigational Site
National City, California, United States
Regeneron Investigational Site
Santa Ana, California, United States
Regeneron Investigational Site
Milford, Connecticut, United States
Regeneron Investigational Site
Stamford, Connecticut, United States
Regeneron Investigational Site
Clearwater, Florida, United States
...and 20 more locations