Clinical trial NCT03776318: Long-Term Follow-up Safety of Clonidine Micropellets
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbosacral Radiculopathy
Lead sponsor: Sollis Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Comprised of the first 100 subjects who completed all STX-015-18-01 study-related activities, age 18-70, male/female, reconfirmed eligible and signed informed consent.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Average and Worst NRS from Day 60 post injection to 12 months post injection
timeFrame: 10 months from completing Day 60 of the STX-015-18-01 study
Secondary outcomes:
measure: Incidence of Surgeries
timeFrame: 12 months from day of injection
measure: Incidence of Invasive treatment received
timeFrame: 12 months from day of injection
measure: Number of Prescription medications taken
timeFrame: 12 months from day of injection
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Sollis Clinical Study Site 36
state: Alabama
city: Phoenix
country: United States
facility: Sollis Clinical Study Site 44
state: Arizona
city: Tucson
country: United States
facility: Sollis Clinical Study Site 40
state: Arizona
city: Rancho Mirage
country: United States
facility: Sollis Clinical Study Site 49
state: California
city: Washington
country: United States
facility: Sollis Clinical Study Site 30
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Sollis Clinical Study Site 35
state: Florida
city: Miami
country: United States
facility: Sollis Clinical Study Site 38
state: Florida
city: Bloomington
country: United States
facility: Sollis Clinical Study Site 12
state: Illinois
city: Chicago
country: United States
facility: Sollis Clinical Study Site 13
state: Illinois
city: Kansas City
country: United States
facility: Sollis Clinical Study Site 14
state: Kansas
city: Overland Park
country: United States
facility: Sollis Clinical Study Site 37
state: Kansas
city: Edgewood
country: United States
facility: Sollis Clinical Study Site 10
state: Kentucky
city: Brookline
country: United States
facility: Sollis Clinical Study Site 15
state: Massachusetts
city: Shrewsbury
country: United States
facility: Sollis Clinical Study Site 17
state: New Jersey
city: Rochester
country: United States
facility: Sollis Clinical Study Site 31
state: New York
city: Winston-Salem
country: United States
facility: Sollis Clinical Study Site 18
state: North Carolina
city: Cleveland
country: United States
facility: Sollis Clinical Study Site 21
state: Ohio
city: Cleveland
country: United States
facility: Sollis Clinical Study Site 33
state: Ohio
city: Edmond
country: United States
facility: Sollis Clinical Study Site 19
state: Oklahoma
city: Eugene
country: United States
facility: Sollis Clinical Study Site 46
state: Oregon
city: Dallas
country: United States
facility: Sollis Clinical Study Site 42
state: Texas
city: Houston
country: United States
facility: Sollis Clinical Study Site 34
state: Texas
city: Salt Lake City
country: United States
facility: Sollis Clinical Study Site 47
state: Utah
city: Morgantown
country: United States
facility: Sollis Clinical Study Site 23
state: West Virginia
city: Madison
country: United States
facility: Sollis Clinical Study Site 27
state: Wisconsin
Study officials:
affiliation: Brigham and Women's Hospital
name: Christopher Gilligan, MD
role: PRINCIPAL_INVESTIGATOR
References: