NCT03776318

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 1, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

2.2 years

First QC Date

December 1, 2018

Last Update Submit

October 5, 2023

Conditions

Lumbosacral Radiculopathy

Outcome Measures

Primary Outcomes (1)

  • 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

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

Secondary Outcomes (3)

  • Incidence of Surgeries

    12 months from day of injection

  • Incidence of Invasive treatment received

    12 months from day of injection

  • Number of Prescription medications taken

    12 months from day of injection

Study Arms (2)

Safety Group

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

Drug: Long-Term Safety Follow-up

Sham Control

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

Drug: Long-Term Safety Follow-up

Interventions

Long-Term Safety Follow-upDRUG

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

Safety GroupSham Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Sollis Clinical Study Site 36

Mobile, Alabama, 36605, United States

Location

Sollis Clinical Study Site 44

Phoenix, Arizona, 85053, United States

Location

Sollis Clinical Study Site 40

Tucson, Arizona, 85724, United States

Location

Sollis Clinical Study Site 49

Rancho Mirage, California, 92270, United States

Location

Sollis Clinical Study Site 30

Washington D.C., District of Columbia, 22205, United States

Location

Sollis Clinical Study Site 35

Fort Lauderdale, Florida, 33316, United States

Location

Sollis Clinical Study Site 38

Miami, Florida, 33135, United States

Location

Sollis Clinical Study Site 12

Bloomington, Illinois, 61704, United States

Location

Sollis Clinical Study Site 13

Chicago, Illinois, 60657, United States

Location

Sollis Clinical Study Site 14

Kansas City, Kansas, 66160, United States

Location

Sollis Clinical Study Site 37

Overland Park, Kansas, 66210, United States

Location

Sollis Clinical Study Site 10

Edgewood, Kentucky, 41017, United States

Location

Sollis Clinical Study Site 15

Brookline, Massachusetts, 02445, United States

Location

Sollis Clinical Study Site 17

Shrewsbury, New Jersey, 07702, United States

Location

Sollis Clinical Study Site 31

Rochester, New York, 14618, United States

Location

Sollis Clinical Study Site 18

Winston-Salem, North Carolina, 27103, United States

Location

Sollis Clinical Study Site 21

Cleveland, Ohio, 44106, United States

Location

Sollis Clinical Study Site 33

Cleveland, Ohio, 44195, United States

Location

Sollis Clinical Study Site 19

Edmond, Oklahoma, 73013, United States

Location

Sollis Clinical Study Site 46

Eugene, Oregon, 97401, United States

Location

Sollis Clinical Study Site 42

Dallas, Texas, 75240, United States

Location

Sollis Clinical Study Site 34

Houston, Texas, 77004, United States

Location

Sollis Clinical Study Site 47

Salt Lake City, Utah, 84107, United States

Location

Sollis Clinical Study Site 23

Morgantown, West Virginia, 26506, United States

Location

Sollis Clinical Study Site 27

Madison, Wisconsin, 53792, United States

Location

Study Officials

  • Christopher Gilligan, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2018

First Posted

December 14, 2018

Study Start

November 15, 2018

Primary Completion

January 22, 2021

Study Completion

May 31, 2021

Last Updated

October 6, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(25)