Clinical trial NCT03727100: Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults
Official title: A Prospective, Multicenter, Randomized, Double-Blinded, Sham-Control Study to Evaluate the Efficacy and Safety of Clonidine Micropellets for the Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lumbosacral Radiculopathy
Lead sponsor: Sollis Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Lotus Clinical Research, LLC
First posted: 2018-11-01
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clonidine Micropellet vs Sham-Control
Primary purpose: TREATMENT

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.


Eligibility criteria: Main Inclusion Criteria:

1. Be between 18 and 70 years of age (inclusive) at time the Informed Consent Form (ICF) is signed.
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.

Main Exclusion Criteria:

1. Medical condition or radiographic evidence that, in the Investigator's opinion, could adversely impact study outcomes.
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.

Primary outcomes:
measure: Pain Intensity Difference (PID) for the average pain Numeric Rating Scale (NRS) from baseline to D30 in radicular leg pain
timeFrame: Baseline to day 60
Secondary outcomes:
measure: Change in Oswestry Disability Index (ODI) score
timeFrame: Baseline to day 30
measure: Change in Numeric Rating Scale (NRS) leg pain 24 hrs post injection.
timeFrame: 1 day post injection
measure: Difference in Rescue medication consumption
timeFrame: Baseline to day 30
measure: Percent of subjects with significant improvement in pain
timeFrame: Baseline to day 30
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 #41
state: Arizona
city: Phoenix
country: United States
facility: Sollis Clinical Study Site #44
state: Arizona
city: Scottsdale
country: United States
facility: Sollis Clinical Study Site 29
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: Santa Rosa
country: United States
facility: Sollis Clinical Study Site 28
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
state: Kansas
city: Edgewood
country: United States
facility: Sollis Clinical Study Site 10
state: Kentucky
city: Boston
country: United States
facility: Sollis Clinical Study Site 16
state: Massachusetts
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: Albany
country: United States
facility: Sollis Clinical Study Site 25
state: New York
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
state: Texas
city: Houston
country: United States
facility: Sollis Clinical Study Site 34
state: Texas
city: San Antonio
country: United States
facility: Sollis Clinical Study Site 22
state: Texas
city: The Woodlands
country: United States
facility: Sollis Clinical Study Site 43
state: Texas
city: Tyler
country: United States
facility: Sollis Clinical Study Site 20
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: