Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults
NCT ID: NCT03727100
Last Updated: 2023-10-06
Study Results
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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COMPLETED
PHASE3
207 participants
INTERVENTIONAL
2018-10-16
2020-07-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Clonidine Micropellets
single dose injection into the lumbar epidural space
Clonidine Micropellets
Injection
Sham Control
non-epidural needle placement
Sham
Injection
Interventions
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Clonidine Micropellets
Injection
Sham
Injection
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of unilateral radicular leg pain.
3. Women of childbearing potential must have a negative pregnancy test at Screening and within 24 hours prior to procedure and commit to adequate birth control during the the study.
4. Understands the purpose and any risks associated with the procedure required for the study and is willing to participate in the study.
5. Agrees to follow study-specific medication requirements.
6. Be able to read, write, understand, and complete study-related tasks, and adequately communicate in English.
7. Subject must have failed at least one conservative therapy in two different categories.
Exclusion Criteria
2. Received an lumbar epidural steroid injection, nerve block or similar procedure during the 4 weeks prior to Screening.
3. Female subjects who are pregnant or breastfeeding.
4. History of lumbar surgery.
18 Years
70 Years
ALL
No
Sponsors
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Lotus Clinical Research, LLC
OTHER
Sollis Therapeutics, Inc.
INDUSTRY
Responsible Party
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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
Sollis Clinical Study Site #41
Phoenix, Arizona, United States
Sollis Clinical Study Site #44
Phoenix, Arizona, United States
Sollis Clinical Study Site 29
Scottsdale, 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 28
Santa Rosa, California, United States
Sollis Clinical Study Site 30
Washington D.C., 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
Sollis Clinical Study Site
Overland Park, Kansas, United States
Sollis Clinical Study Site 10
Edgewood, Kentucky, United States
Sollis Clinical Study Site 16
Boston, Massachusetts, United States
Sollis Clinical Study Site 15
Brookline, Massachusetts, United States
Sollis Clinical Study Site 17
Shrewsbury, New Jersey, United States
Sollis Clinical Study Site 25
Albany, New York, United States
Sollis Clinical Study Site 31
Rochester, New York, United States
Sollis Clinical Study Site 18
Winston-Salem, North Carolina, United States
Sollis Clinical Study Site 21
Cleveland, Ohio, United States
Sollis Clinical Study Site 33
Cleveland, Ohio, United States
Sollis Clinical Study Site 19
Edmond, Oklahoma, United States
Sollis Clinical Study Site 46
Eugene, Oregon, United States
Sollis Clinical Study Site
Dallas, Texas, United States
Sollis Clinical Study Site 34
Houston, Texas, United States
Sollis Clinical Study Site 22
San Antonio, Texas, United States
Sollis Clinical Study Site 43
The Woodlands, Texas, United States
Sollis Clinical Study Site 20
Tyler, Texas, United States
Sollis Clinical Study Site 47
Salt Lake City, Utah, United States
Sollis Clinical Study Site 23
Morgantown, West Virginia, United States
Sollis Clinical Study Site 27
Madison, Wisconsin, United States
Countries
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Other Identifiers
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STX-015-18-01
Identifier Type: -
Identifier Source: org_study_id
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