Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults
- Conditions
- Lumbosacral Radiculopathy
- Interventions
- Combination Product: Clonidine MicropelletsOther: Sham
- Registration Number
- NCT03727100
- Lead Sponsor
- Sollis Therapeutics, Inc.
- Brief Summary
This study will evaluate the safety and effectiveness of a new pain medication in development, clonidine micropellet. Participants will receive a single injection of either clonidine micropellet or sham injection for the treatment of low back and leg pain from sciatica.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 207
- Be between 18 and 70 years of age (inclusive) at time the Informed Consent Form (ICF) is signed.
- Diagnosis of unilateral radicular leg pain.
- 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.
- Understands the purpose and any risks associated with the procedure required for the study and is willing to participate in the study.
- Agrees to follow study-specific medication requirements.
- Be able to read, write, understand, and complete study-related tasks, and adequately communicate in English.
- Subject must have failed at least one conservative therapy in two different categories.
Main
- Medical condition or radiographic evidence that, in the Investigator's opinion, could adversely impact study outcomes.
- Received an lumbar epidural steroid injection, nerve block or similar procedure during the 4 weeks prior to Screening.
- Female subjects who are pregnant or breastfeeding.
- History of lumbar surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clonidine Micropellets Clonidine Micropellets single dose injection into the lumbar epidural space Sham Control Sham non-epidural needle placement
- Primary Outcome Measures
Name Time Method Pain Intensity Difference (PID) for the average pain Numeric Rating Scale (NRS) from baseline to D30 in radicular leg pain Baseline to day 60 Difference in average pain score, using a scale of 0-10 with 0 no pain and 10 worst possible pain, from baseline to day 30.
- Secondary Outcome Measures
Name Time Method Change in Oswestry Disability Index (ODI) score Baseline to day 30 6 categories of 10 question, each question is scored from 0-5 (minimum to maximum). The scores range from 0-100% with lower scores meaning less disability.
Change in Numeric Rating Scale (NRS) leg pain 24 hrs post injection. 1 day post injection Difference in average pain score, using a scale of 0-10 with 0 no pain and 10 worst possible pain, from injection to 24 hrs post injection.
Percent of subjects with significant improvement in pain Baseline to day 30 50 percent improvement in pain from baseline to day 30
Difference in Rescue medication consumption Baseline to day 30 Consumption from baseline through day 30
Trial Locations
- Locations (32)
Sollis Clinical Study Site 35
🇺🇸Fort Lauderdale, Florida, United States
Sollis Clinical Study Site 14
🇺🇸Kansas City, Kansas, United States
Sollis Clinical Study Site 16
🇺🇸Boston, Massachusetts, United States
Sollis Clinical Study Site 38
🇺🇸Miami, Florida, United States
Sollis Clinical Study Site 22
🇺🇸San Antonio, Texas, United States
Sollis Clinical Study Site 47
🇺🇸Salt Lake City, Utah, United States
Sollis Clinical Study Site 36
🇺🇸Mobile, Alabama, United States
Sollis Clinical Study Site 21
🇺🇸Cleveland, Ohio, United States
Sollis Clinical Study Site 43
🇺🇸The Woodlands, Texas, United States
Sollis Clinical Study Site 31
🇺🇸Rochester, New York, United States
Sollis Clinical Study Site 19
🇺🇸Edmond, Oklahoma, United States
Sollis Clinical Study Site 40
🇺🇸Tucson, Arizona, United States
Sollis Clinical Study Site 33
🇺🇸Cleveland, Ohio, United States
Sollis Clinical Study Site 46
🇺🇸Eugene, Oregon, United States
Sollis Clinical Study Site 25
🇺🇸Albany, New York, United States
Sollis Clinical Study Site 20
🇺🇸Tyler, Texas, United States
Sollis Clinical Study Site 34
🇺🇸Houston, Texas, United States
Sollis Clinical Study Site #41
🇺🇸Phoenix, Arizona, United States
Sollis Clinical Study Site 29
🇺🇸Scottsdale, Arizona, United States
Sollis Clinical Study Site 30
🇺🇸Washington, District of Columbia, United States
Sollis Clinical Study Site 13
🇺🇸Chicago, Illinois, United States
Sollis Clinical Study Site 28
🇺🇸Santa Rosa, California, United States
Sollis Clinical Study Site 12
🇺🇸Bloomington, Illinois, United States
Sollis Clinical Study Site 49
🇺🇸Rancho Mirage, California, United States
Sollis Clinical Study Site
🇺🇸Dallas, Texas, 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 10
🇺🇸Edgewood, Kentucky, United States
Sollis Clinical Study Site 23
🇺🇸Morgantown, West Virginia, United States
Sollis Clinical Study Site 27
🇺🇸Madison, Wisconsin, United States
Sollis Clinical Study Site #44
🇺🇸Phoenix, Arizona, United States
Sollis Clinical Study Site 18
🇺🇸Winston-Salem, North Carolina, United States