Trials / Terminated
TerminatedNCT05614648
Sciatica Epidural Radiculopathy Experimental New Interventional TherapY Clonidine Micropellet
A Phase 3, Prospective, Multicenter, Randomized, Double-blind, Sham-controlled Study of the Efficacy and Safety of STX-015 in the Treatment of Pain Associated With Lumbosacral Radiculopathy
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Sollis Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-06-19
- Primary completion
- 2024-03-18
- Completion
- 2024-03-30
- First posted
- 2022-11-14
- Last updated
- 2024-04-25
Locations
30 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05614648. Inclusion in this directory is not an endorsement.