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Sciatica Epidural Radiculopathy Experimental New Interventional TherapY Clonidine Micropellet

NCT05614648 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-04-25

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

DRUG

Clonidine Micropellets

0.975 mg clonidine hydrochloride as 3 micropellets administered in one injection

DEVICE

Tuohy epidural needle

18-gauge Tuohy epidural needle using a custom-built injector

Sponsors & Collaborators

  • Sollis Therapeutics, Inc.

    lead INDUSTRY

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
2023-06-19
Primary Completion
2024-03-18
Completion
2024-03-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05614648 on ClinicalTrials.gov