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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00991172
First received: September 4, 2009
Last updated: December 1, 2011
Last verified: December 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Additional measures of sciatic pain. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00991172

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

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00991172     History of Changes
Other Study ID Numbers: R475-PN-0908
Study First Received: September 4, 2009
Last Updated: December 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Regeneron Pharmaceuticals:
sciatica
sciatic pain
pain
back pain

Additional relevant MeSH terms:
Sciatica
Mononeuropathies
Nervous System Diseases
Neuralgia
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Sciatic Neuropathy
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014