Lumbosacral Radiculopathy
Conditions
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.
Interventions
COMBINATION_PRODUCTClonidine Micropellets
Injection
OTHERSham
Injection
Sponsors
Lotus Clinical Research, LLC
Sollis Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double-Blinded
Intervention model description
Clonidine Micropellet vs Sham-Control
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Difference in Rescue medication consumption | Baseline to day 30 | Consumption from baseline through day 30 |
| Percent of subjects with significant improvement in pain | Baseline to day 30 | 50 percent improvement in pain from baseline to day 30 |
Countries
United States
Outcome results
None listed