Lumbosacral RadiculopathyPhase 3RePRIEVE-CMNCT03727100
Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults
A Phase 3 study testing Clonidine Micropellets in people with Lumbosacral Radiculopathy, run by Sollis Therapeutics, Inc. at 33 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbosacral Radiculopathy
- What is being tested?
- Clonidine Micropellets
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 33 sitesUnited States
- Study dates
- 16 Oct 2018to 18 Jul 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- 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 Exclusion Criteria:
- 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.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Sollis Clinical Study Site 25
Albany, New York, 12208
Sollis Clinical Study Site 12
Bloomington, Illinois, 61704
Sollis Clinical Study Site 16
Boston, Massachusetts, 02115
Sollis Clinical Study Site 15
Brookline, Massachusetts, 02445
Sollis Clinical Study Site 13
Chicago, Illinois, 60657
Sollis Clinical Study Site 21
Cleveland, Ohio, 44106
Sollis Clinical Study Site 33
Cleveland, Ohio, 44195
Sollis Clinical Study Site
Dallas, Texas, 75240
Sollis Clinical Study Site 10
Edgewood, Kentucky, 41017
Sollis Clinical Study Site 19
Edmond, Oklahoma, 73013
Sollis Clinical Study Site 46
Eugene, Oregon, 97401
Sollis Clinical Study Site 35
Fort Lauderdale, Florida, 33316
Sollis Clinical Study Site 34
Houston, Texas, 77004
Sollis Clinical Study Site 14
Kansas City, Kansas, 66160
Sollis Clinical Study Site 27
Madison, Wisconsin, 53792
Sollis Clinical Study Site 38
Miami, Florida, 33135
Sollis Clinical Study Site 36
Mobile, Alabama, 36605
Sollis Clinical Study Site 23
Morgantown, West Virginia, 26505
Sollis Clinical Study Site
Overland Park, Kansas, 66210
Sollis Clinical Study Site #41
Phoenix, Arizona, 85018
Sollis Clinical Study Site #44
Phoenix, Arizona, 85053
Sollis Clinical Study Site 49
Rancho Mirage, California, 92270
Sollis Clinical Study Site 31
Rochester, New York, 14620
Sollis Clinical Study Site 47
Salt Lake City, Utah, 84107
Sollis Clinical Study Site 22
San Antonio, Texas, 78229
Sollis Clinical Study Site 28
Santa Rosa, California, 95401
Sollis Clinical Study Site 29
Scottsdale, Arizona, 85258
Sollis Clinical Study Site 17
Shrewsbury, New Jersey, 60657
Sollis Clinical Study Site 43
The Woodlands, Texas, 77382
Sollis Clinical Study Site 40
Tucson, Arizona, 85724
Sollis Clinical Study Site 20
Tyler, Texas, 75701
Sollis Clinical Study Site 30
Washington D.C., District of Columbia, 22205
Sollis Clinical Study Site 18
Winston-Salem, North Carolina, 27103
About this study
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
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.
- Conditions
- Lumbosacral Radiculopathy
- Being tested
- Clonidine Micropellets, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clonidine MicropelletsCombination product
Injection
ShamOther
Injection
| Study group | Role | What they receive |
|---|---|---|
| Clonidine Micropellets | Active comparator | single dose injection into the lumbar epidural space Receives: Combination Product: Clonidine Micropellets |
| Sham Control | Sham comparator | non-epidural needle placement Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Difference (PID) for the average pain Numeric Rating Scale (NRS) from baseline to D30 in radicular leg pain
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.
Measured: Baseline to day 60
Secondary outcomes (4)
Change in Oswestry Disability Index (ODI) score
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.
Measured: Baseline to day 30
Change in Numeric Rating Scale (NRS) leg pain 24 hrs 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.
Measured: 1 day post injection
Difference in Rescue medication consumption
Consumption from baseline through day 30
Measured: Baseline to day 30
Percent of subjects with significant improvement in pain
50 percent improvement in pain from baseline to day 30
Measured: Baseline to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start16 Oct 2018
- Primary completion5 Mar 2020
- Study completion18 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clonidine Micropellet vs Sham-Control
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sollis Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lotus Clinical Research, LLC
- Responsible party
- Sponsor
- Investigators
- Christopher Gilligan, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727100
- Sponsor's protocol ID
- STX-015-18-01
- Acronym
- RePRIEVE-CM
- Status last verified
- Oct 2023
- First submitted
- 30 Oct 2018
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03727100
- Acronym / sponsor ID
- RePRIEVE-CM / STX-015-18-01
- Conditions
- Lumbosacral Radiculopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Sollis Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Lotus Clinical Research, LLC
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 18 Jul 2020 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Clonidine Micropellet vs Sham-Control
| Arm | Type | Receives |
|---|---|---|
| Clonidine Micropellets | Active comparator | Combination Product: Clonidine Micropelletssingle dose injection into the lumbar epidural space |
| Sham Control | Sham comparator | Other: Shamnon-epidural needle placement |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clonidine MicropelletsInjection | Combination product | Clonidine Micropellets |
| ShamInjection | Other | Sham Control |
Primary outcome
Pain Intensity Difference (PID) for the average pain Numeric Rating Scale (NRS) from baseline to D30 in radicular leg pain
Time frame: 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.
4 secondary outcomes
Change in Oswestry Disability Index (ODI) score
Time frame: Baseline to day 30
Change in Numeric Rating Scale (NRS) leg pain 24 hrs post injection.
Time frame: 1 day post injection
Difference in Rescue medication consumption
Time frame: Baseline to day 30
Percent of subjects with significant improvement in pain
Time frame: Baseline to day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Gilligan, MD principal investigator
Brigham and Women's Hospital
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clonidine Micropellets in people with Lumbosacral Radiculopathy, run by Sollis Therapeutics, Inc. at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Difference (PID) for the average pain Numeric Rating Scale (NRS) from baseline to D30 in radicular leg pain (time frame: Baseline to day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.