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

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Sciatic Pain

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00991172

Enrollment

159

Registered

2009-10-07

Start date

2009-11-30

Completion date

2010-05-31

Last updated

2011-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sciatica

Keywords

sciatica, sciatic pain, pain, back pain

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.

Interventions

DRUGREGN475

Single Subcutaneous injection dose level 1

DRUGPlacebo Injection

Placebo Subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Sciatic pain between baseline and end of week 4	4 weeks

Secondary

Measure	Time frame
Additional measures of sciatic pain.	6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026