Long-Term Follow-up Safety of Clonidine Micropellets

N/ACompletedNCT03776318

Sollis Therapeutics, Inc.100 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Lumbosacral Radiculopathy

Interventions

Long-Term Safety Follow-upDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (25)

Sollis Clinical Study Site 36

Outcomes

Primary Outcomes

Change in Average and Worst NRS from Day 60 post injection to 12 months post injection

Difference in NRS pain scores from Day 60 of STX-015-18-01 to month 12 post injection

Time frame: 10 months from completing Day 60 of the STX-015-18-01 study

Secondary Outcomes

Incidence of Surgeries

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.

Time frame: 12 months from day of injection

Incidence of Invasive treatment received

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

Time frame: 12 months from day of injection

Number of Prescription medications taken

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

Time frame: 12 months from day of injection

Data from ClinicalTrials.gov

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