Long-Term Follow-up Safety of Clonidine Micropellets

Completed

• Conditions: Lumbosacral Radiculopathy
• Interventions: Drug: Long-Term Safety Follow-up

• Registration Number: NCT03776318
• Lead Sponsor: Sollis Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-15
• Study First Submitted: 2018-12-01
• Study First Submitted QC: 2018-12-12
• Study First Posted: 2018-12-14
• Primary Completion: 2021-01-22
• Study Completion: 2021-05-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sham Control	Long-Term Safety Follow-up	STX-015-18-01 Sham control long-term safety follow-up
Safety Group	Long-Term Safety Follow-up	STX-015-18-01 Clonidine Micropellet long-term safety follow-up

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (25)

Sollis Clinical Study Site 36; 🇺🇸 Mobile, Alabama, United States

Sollis Clinical Study Site 44; 🇺🇸 Phoenix, Arizona, United States

Sollis Clinical Study Site 40; 🇺🇸 Tucson, Arizona, United States

Sollis Clinical Study Site 49; 🇺🇸 Rancho Mirage, California, United States

Sollis Clinical Study Site 30; 🇺🇸 Washington, District of Columbia, United States

Sollis Clinical Study Site 35; 🇺🇸 Fort Lauderdale, Florida, United States

Sollis Clinical Study Site 38; 🇺🇸 Miami, Florida, United States

Sollis Clinical Study Site 12; 🇺🇸 Bloomington, Illinois, United States

Sollis Clinical Study Site 13; 🇺🇸 Chicago, Illinois, United States

Sollis Clinical Study Site 14; 🇺🇸 Kansas City, Kansas, United States

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