MedTrace Logo

Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults

NCT03727100 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2023-10-06

No results posted yet for this study

Summary

This study will evaluate the safety and effectiveness of a new pain medication in development, clonidine micropellet. Participants will receive a single injection of either clonidine micropellet or sham injection for the treatment of low back and leg pain from sciatica.

Conditions

  • Lumbosacral Radiculopathy

Interventions

COMBINATION_PRODUCT

Clonidine Micropellets

Injection

OTHER

Sham

Injection

Sponsors & Collaborators

  • Lotus Clinical Research, LLC

    collaborator OTHER

  • Sollis Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Gilligan, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2020-03-05
Completion
2020-07-18
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03727100 on ClinicalTrials.gov