A Study to Evaluate the Safety and Efficacy of Subcutaneously Administered REGN475(SAR164877) in Patients With Sciatic Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Sciatica

In brief

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.

Key facts

Study ID

NCT00991172

Run by

Regeneron Pharmaceuticals

People needed

159

Starts

2009-11-01

Expected to finish

2010-05-01

Last updated by the study team

2011-12-08

Who can join

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

You may qualify if…

• Pain present for at least 2 weeks, but not lasting for more than 16 weeks prior to the screening visit.
• A confirmed diagnosis of sciatica at the screening visit.
• Weight less than 120 kg

You may not qualify if…

• Back surgery within 6 months prior to the screening visit
• Neurological deficit (muscle weakness and/or reflex loss; loss of bowel or bladder function) from any cause including sciatica
• Other conditions which may confound the interpretation of the study, such as carpal tunnel syndrome, MS, rheumatoid arthritis, spinal stenosis, etc.
• Allergy to doxycycline or related compounds
• Women who are pregnant or nursing

Where it is running

• 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
• Regeneron Investigational Site — Hallandale, Florida, United States
• Regeneron Investigational Site — St. Petersburg, Florida, United States
• Regeneron Investigational Site — Tampa, Florida, United States
• Regeneron Investigational Site — West Palm Beach, Florida, United States
• Regeneron Investigational Site — Atlanta, Georgia, United States
• Regeneron Investigational Site — Sandy Springs, Georgia, United States
• Regeneron Investigational Site — Overland Park, Kansas, United States
• Regeneron Investigational Site — Rockville, Maryland, United States
• Regeneron Investigational Site — Kansas City, Missouri, United States
• Regeneron Investigational Site — Albuquerque, New Mexico, United States
• Regeneron Investigational Site — Raleigh, North Carolina, United States
• Regeneron Investigational Site — Cincinnati, Ohio, United States
• Regeneron Investigational Site — Duncansville, Pennsylvania, United States
• Regeneron Investigational Site — Tyrone, Pennsylvania, United States
• Regeneron Investigational Site — Warwick, Rhode Island, United States

Full record on ClinicalTrials.gov

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