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

Primary Purpose

Sciatica

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
REGN475
REGN475
Placebo Injection
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sciatica focused on measuring sciatica, sciatic pain, pain, back pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Investigational Site
  • Regeneron Invesitgational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

placebo injection

active

active 2

Arm Description

subcutaneous injection of REGN475

subcutaneous injection of REGN475

Outcomes

Primary Outcome Measures

Sciatic pain between baseline and end of week 4

Secondary Outcome Measures

Additional measures of sciatic pain.

Full Information

First Posted
September 4, 2009
Last Updated
December 1, 2011
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00991172
Brief Title
A Study to Evaluate the Safety and Efficacy of Subcutaneously Administered REGN475(SAR164877) in Patients With Sciatic Pain
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 Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatica
Keywords
sciatica, sciatic pain, pain, back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo injection
Arm Type
Placebo Comparator
Arm Title
active
Arm Type
Experimental
Arm Description
subcutaneous injection of REGN475
Arm Title
active 2
Arm Type
Experimental
Arm Description
subcutaneous injection of REGN475
Intervention Type
Drug
Intervention Name(s)
REGN475
Intervention Description
Single Subcutaneous injection dose level 1
Intervention Type
Drug
Intervention Name(s)
REGN475
Intervention Description
Single subcutaneous injection dose level 2
Intervention Type
Drug
Intervention Name(s)
Placebo Injection
Intervention Description
Placebo Subcutaneous injection
Primary Outcome Measure Information:
Title
Sciatic pain between baseline and end of week 4
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Additional measures of sciatic pain.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pain present for at least 2 weeks, but not lasting for more than 16 weeks prior to the screening visit. A confirmed diagnosis of sciatica at the screening visit. Weight less than 120 kg Exclusion Criteria: Back surgery within 6 months prior to the screening visit Neurological deficit (muscle weakness and/or reflex loss; loss of bowel or bladder function) from any cause including sciatica Other conditions which may confound the interpretation of the study, such as carpal tunnel syndrome, MS, rheumatoid arthritis, spinal stenosis, etc. Allergy to doxycycline or related compounds Women who are pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Tiseo, PhD
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Regeneron Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Regeneron Investigational Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Regeneron Investigational Site
City
Peoria
State/Province
Arizona
Country
United States
Facility Name
Regeneron Investigational Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
Regeneron Investigational Site
City
Beverly Hills
State/Province
California
Country
United States
Facility Name
Regeneron Investigational Site
City
National City
State/Province
California
Country
United States
Facility Name
Regeneron Investigational Site
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Regeneron Investigational Site
City
Milford
State/Province
Connecticut
Country
United States
Facility Name
Regeneron Investigational Site
City
Stamford
State/Province
Connecticut
Country
United States
Facility Name
Regeneron Investigational Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Regeneron Investigational Site
City
Hallandale Beach
State/Province
Florida
Country
United States
Facility Name
Regeneron Investigational Site
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
Regeneron Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Regeneron Investigational Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Regeneron Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Regeneron Investigational Site
City
Sandy Springs
State/Province
Georgia
Country
United States
Facility Name
Regeneron Investigational Site
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Regeneron Investigational Site
City
Rockville
State/Province
Maryland
Country
United States
Facility Name
Regeneron Investigational Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Regeneron Investigational Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Regeneron Investigational Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Regeneron Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Regeneron Investigational Site
City
Duncansville
State/Province
Pennsylvania
Country
United States
Facility Name
Regeneron Investigational Site
City
Tyrone
State/Province
Pennsylvania
Country
United States
Facility Name
Regeneron Investigational Site
City
Warwick
State/Province
Rhode Island
Country
United States
Facility Name
Regeneron Investigational Site
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
Regeneron Investigational Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Regeneron Investigational Site
City
El Paso
State/Province
Texas
Country
United States
Facility Name
Regeneron Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Regeneron Invesitgational Site
City
West Jordan
State/Province
Utah
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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