Long-Term Follow-up Safety of Clonidine Micropellets

NCT ID: NCT03776318

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-15

Study Completion Date

2021-05-31

Brief Summary

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

Detailed Description

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Conditions

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Lumbosacral Radiculopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Safety Group

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

Long-Term Safety Follow-up

Intervention Type DRUG

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

Sham Control

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

Long-Term Safety Follow-up

Intervention Type DRUG

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

Interventions

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Long-Term Safety Follow-up

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sollis Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Gilligan, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Sollis Clinical Study Site 36

Mobile, Alabama, United States

Site Status

Sollis Clinical Study Site 44

Phoenix, Arizona, United States

Site Status

Sollis Clinical Study Site 40

Tucson, Arizona, United States

Site Status

Sollis Clinical Study Site 49

Rancho Mirage, California, United States

Site Status

Sollis Clinical Study Site 30

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

Site Status

Sollis Clinical Study Site 35

Fort Lauderdale, Florida, United States

Site Status

Sollis Clinical Study Site 38

Miami, Florida, United States

Site Status

Sollis Clinical Study Site 12

Bloomington, Illinois, United States

Site Status

Sollis Clinical Study Site 13

Chicago, Illinois, United States

Site Status

Sollis Clinical Study Site 14

Kansas City, Kansas, United States

Site Status

Sollis Clinical Study Site 37

Overland Park, Kansas, United States

Site Status

Sollis Clinical Study Site 10

Edgewood, Kentucky, United States

Site Status

Sollis Clinical Study Site 15

Brookline, Massachusetts, United States

Site Status

Sollis Clinical Study Site 17

Shrewsbury, New Jersey, United States

Site Status

Sollis Clinical Study Site 31

Rochester, New York, United States

Site Status

Sollis Clinical Study Site 18

Winston-Salem, North Carolina, United States

Site Status

Sollis Clinical Study Site 21

Cleveland, Ohio, United States

Site Status

Sollis Clinical Study Site 33

Cleveland, Ohio, United States

Site Status

Sollis Clinical Study Site 19

Edmond, Oklahoma, United States

Site Status

Sollis Clinical Study Site 46

Eugene, Oregon, United States

Site Status

Sollis Clinical Study Site 42

Dallas, Texas, United States

Site Status

Sollis Clinical Study Site 34

Houston, Texas, United States

Site Status

Sollis Clinical Study Site 47

Salt Lake City, Utah, United States

Site Status

Sollis Clinical Study Site 23

Morgantown, West Virginia, United States

Site Status

Sollis Clinical Study Site 27

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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STX-015-18-02

Identifier Type: -

Identifier Source: org_study_id

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