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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00991172
Recruitment Status : Completed
First Posted : October 7, 2009
Last Update Posted : December 8, 2011
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sciatica Drug: REGN475 Drug: Placebo Injection Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
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
Study Start Date : November 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sciatica

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00991172

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Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Paul Tiseo, PhD Regeneron Pharmaceuticals

Responsible Party: Regeneron Pharmaceuticals Identifier: NCT00991172     History of Changes
Other Study ID Numbers: R475-PN-0908
First Posted: October 7, 2009    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 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