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

Phase 2

Completed

• Conditions: Sciatica
• Interventions: Drug: Placebo Injection; Drug: REGN475

• Registration Number: NCT00991172
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-04
• Study First Submitted QC: 2009-10-05
• Study First Posted: 2009-10-07
• Study Start: 2009-11
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Disposition First Submitted: 2011-03-17
• Disposition First Submitted QC: 2011-03-17
• Disposition First Posted: 2011-03-28
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-01
• Last Update Posted: 2011-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo injection	Placebo Injection	-
active	REGN475	subcutaneous injection of REGN475
active 2	REGN475	subcutaneous injection of REGN475

Primary Outcome Measures

Name	Time	Method
Sciatic pain between baseline and end of week 4	4 weeks

Secondary Outcome Measures

Name	Time	Method
Additional measures of sciatic pain.	6 weeks

Trial Locations

Locations (2)

Regeneron Investigational Site; 🇺🇸 San Antonio, Texas, United States

Regeneron Invesitgational Site; 🇺🇸 West Jordan, Utah, United States