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CompletedNCT00991172Updated Dec 8, 2011

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

A Phase 2 interventional study of REGN475 and REGN475 in Sciatica, sponsored by Regeneron Pharmaceuticals. Completed at 30 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-12-08.

Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
159
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sciatica

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Keywords

  • sciatica
  • sciatic pain
  • pain
  • back pain
03

In context

Sciatica

139 studies on the registry are indexed under Sciatica; 29 are open to participants now.

This study's enrollment of 159 is above the median of 66 across 111 interventional studies indexed under Sciatica.

Browse Sciatica studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
159 participants (actual)

Study arms

  • Placebo comparator
    placebo injection

    Drug: Placebo Injection

  • Experimental
    active

    subcutaneous injection of REGN475

    Drug: REGN475

  • Experimental
    active 2

    subcutaneous injection of REGN475

    Drug: REGN475

Interventions

  • DrugREGN475

    Single Subcutaneous injection dose level 1

  • DrugREGN475

    Single subcutaneous injection dose level 2

  • DrugPlacebo Injection

    Placebo Subcutaneous injection

06

What researchers measure

Primary outcomes

  1. Sciatic pain between baseline and end of week 4

    Time frame: 4 weeks

Secondary outcomes

  1. Additional measures of sciatic pain.

    Time frame: 6 weeks

07

Study locations

30 sites
  • Regeneron Investigational Site
    Birmingham, Alabama, United States
  • Regeneron Investigational Site
    Mobile, Alabama, United States
  • Regeneron Investigational Site
    Peoria, Arizona, United States
  • 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
  • Regeneron Investigational Site
    Milford, Connecticut, United States
  • Regeneron Investigational Site
    Stamford, Connecticut, United States
  • 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
  • Regeneron Investigational Site
    Atlanta, Georgia, United States
  • Regeneron Investigational Site
    Sandy Springs, Georgia, United States
  • Regeneron Investigational Site
    Overland Park, Kansas, United States
  • Regeneron Investigational Site
    Rockville, Maryland, United States
  • Regeneron Investigational Site
    Kansas City, Missouri, United States
  • Regeneron Investigational Site
    Albuquerque, New Mexico, United States
  • Regeneron Investigational Site
    Raleigh, North Carolina, United States
  • Regeneron Investigational Site
    Cincinnati, Ohio, United States
  • Regeneron Investigational Site
    Duncansville, Pennsylvania, United States
  • Regeneron Investigational Site
    Tyrone, Pennsylvania, United States
  • Regeneron Investigational Site
    Warwick, Rhode Island, United States
  • Regeneron Investigational Site
    Greer, South Carolina, United States
  • Regeneron Investigational Site
    Memphis, Tennessee, United States
  • Regeneron Investigational Site
    El Paso, Texas, United States
  • Regeneron Investigational Site
    San Antonio, Texas, United States
  • Regeneron Invesitgational Site
    West Jordan, Utah, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00991172
Lead sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
Responsible party
Sponsor
First posted
Oct 7, 2009
Start date
Nov 2009
Primary completion
May 2010
Completion
May 2010
Last update
Dec 8, 2011

Study contacts

Paul Tiseo, PhD
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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