NCT00991172|CompletedPhase 2DMC

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

Regeneron Pharmaceuticals ClinicalTrials.gov

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1 other identifier

R475-PN-0908

Study Type

interventional

Target

159

Locations

1 country

Sites

Timeline

RegisteredOct 2009

StartedNov 2009

CompletionMay 2010

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

159

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2009

Shorter than P25 for phase_2

Geographic Reach

1 country

30 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

First Submitted

Initial submission to the registry

September 4, 2009

Completed

1 month until next milestone

First Posted

Study publicly available on registry

October 7, 2009

Completed

25 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed

Last Updated

December 8, 2011

Status Verified

December 1, 2011

Enrollment Period

6 months

First QC Date

September 4, 2009

Last Update Submit

December 1, 2011

Conditions

Sciatica

Keywords

sciaticasciatic painpainback pain

Outcome Measures

Primary Outcomes (1)

Sciatic pain between baseline and end of week 4
4 weeks

Secondary Outcomes (1)

Additional measures of sciatic pain.
6 weeks

Study Arms (3)

placebo injection

PLACEBO COMPARATOR

Drug: Placebo Injection

active

EXPERIMENTAL

subcutaneous injection of REGN475

Drug: REGN475

active 2

EXPERIMENTAL

subcutaneous injection of REGN475

Drug: REGN475

Interventions

REGN475DRUG

Single Subcutaneous injection dose level 1

active

Placebo InjectionDRUG

Placebo Subcutaneous injection

placebo injection

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.