Long-Term Follow-up Safety of Clonidine Micropellets

A Multicenter, Randomized, Follow-up Study to Evaluate the Long-Term Safety of Clonidine Micropellets for the Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03776318

Acronym

RePRIEVE-CM-LT

Enrollment

100

Registered

2018-12-14

Start date

2018-11-15

Completion date

2021-05-31

Last updated

2023-10-06

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

Conditions

Lumbosacral Radiculopathy

Brief summary

Long-term follow-up study to evaluate the safety of clonidine micropellets up to 12 months post injection.

Interventions

DRUGLong-Term Safety Follow-up

STX-015-18-01 long-term safety follow-up

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Subject who have successfully completed all STX-015-18-01 study related activities, are reconfirmed to be eligible and have signed informed consent to participate.

Exclusion criteria

* Subjects who, in the opinion of the investigator, have demonstrated significant non-compliance with STX-015-18-01 study procedures. * Subjects who were unblinded to their treatment in STX-015-18-01 study.

Design outcomes

Primary

Measure	Time frame	Description
Change in Average and Worst NRS from Day 60 post injection to 12 months post injection	10 months from completing Day 60 of the STX-015-18-01 study	Difference in NRS pain scores from Day 60 of STX-015-18-01 to month 12 post injection

Secondary

Measure	Time frame	Description
Incidence of Surgeries	12 months from day of injection	Difference in incidence of surgery, invasive treatment, and prescription medications due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01.
Incidence of Invasive treatment received	12 months from day of injection	Difference in incidence of invasive treatment due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01
Number of Prescription medications taken	12 months from day of injection	Difference in incidence of invasive treatment due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01

Countries

United States

Outcome results

None listed

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