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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.
 
ClinicalTrials.gov Identifier: NCT00991172
Recruitment Status : Completed
First Posted : October 7, 2009
Last Update Posted : December 8, 2011
Sponsor:
Collaborator:
Sanofi
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

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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

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, Learn About Clinical Studies.


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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT00991172


Locations
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United States, Alabama
Regeneron Investigational Site
Birmingham, Alabama, United States
Regeneron Investigational Site
Mobile, Alabama, United States
United States, Arizona
Regeneron Investigational Site
Peoria, Arizona, United States
United States, California
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
United States, Connecticut
Regeneron Investigational Site
Milford, Connecticut, United States
Regeneron Investigational Site
Stamford, Connecticut, United States
United States, Florida
Regeneron Investigational Site
Clearwater, Florida, United States
Regeneron Investigational Site
Hallandale Beach, 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
United States, Georgia
Regeneron Investigational Site
Atlanta, Georgia, United States
Regeneron Investigational Site
Sandy Springs, Georgia, United States
United States, Kansas
Regeneron Investigational Site
Overland Park, Kansas, United States
United States, Maryland
Regeneron Investigational Site
Rockville, Maryland, United States
United States, Missouri
Regeneron Investigational Site
Kansas City, Missouri, United States
United States, New Mexico
Regeneron Investigational Site
Albuquerque, New Mexico, United States
United States, North Carolina
Regeneron Investigational Site
Raleigh, North Carolina, United States
United States, Ohio
Regeneron Investigational Site
Cincinnati, Ohio, United States
United States, Pennsylvania
Regeneron Investigational Site
Duncansville, Pennsylvania, United States
Regeneron Investigational Site
Tyrone, Pennsylvania, United States
United States, Rhode Island
Regeneron Investigational Site
Warwick, Rhode Island, United States
United States, South Carolina
Regeneron Investigational Site
Greer, South Carolina, United States
United States, Tennessee
Regeneron Investigational Site
Memphis, Tennessee, United States
United States, Texas
Regeneron Investigational Site
El Paso, Texas, United States
Regeneron Investigational Site
San Antonio, Texas, United States
United States, Utah
Regeneron Invesitgational Site
West Jordan, Utah, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Paul Tiseo, PhD Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00991172    
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:
sciatica
sciatic pain
pain
back pain
Additional relevant MeSH terms:
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Sciatica
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neuralgia
Pain
Neurologic Manifestations
Signs and Symptoms
Fasinumab
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs