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

This study has been completed.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals Identifier:
First received: September 4, 2009
Last updated: December 1, 2011
Last verified: December 2011
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.

Condition Intervention Phase
Sciatica Drug: REGN475 Drug: Placebo Injection Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Sciatic Pain

Resource links provided by NLM:

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Sciatic pain between baseline and end of week 4 [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Additional measures of sciatic pain. [ Time Frame: 6 weeks ]

Enrollment: 159
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo injection Drug: Placebo Injection
Placebo Subcutaneous injection
Experimental: active
subcutaneous injection of REGN475
Drug: REGN475
Single Subcutaneous injection dose level 1
Experimental: active 2
subcutaneous injection of REGN475
Drug: REGN475
Single subcutaneous injection dose level 2


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00991172

  Show 30 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Paul Tiseo, PhD Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals Identifier: NCT00991172     History of Changes
Other Study ID Numbers: R475-PN-0908
Study First Received: September 4, 2009
Last Updated: December 1, 2011

Keywords provided by Regeneron Pharmaceuticals:
sciatic pain
back pain

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms processed this record on September 21, 2017