Lumbosacral RadiculopathyRePRIEVE-CM-LTNCT03776318
Long-Term Follow-up Safety of Clonidine Micropellets
An observational study of Lumbosacral Radiculopathy, run by Sollis Therapeutics, Inc. at 25 sites in United States.
Trial summary
Long-term follow-up study to evaluate the safety of clonidine micropellets up to 12 months post injection. 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?
- Long-Term Safety Follow-up
- How many people
- 100 participants
- Where
- 25 sitesUnited States
- Study dates
- 15 Nov 2018to 31 May 2021
- Phase
- Observational
- 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
Study population: Comprised of the first 100 subjects who completed all STX-015-18-01 study-related activities, age 18-70, male/female, reconfirmed eligible and signed informed consent.
Who may be able to join
- Subject who have successfully completed all STX-015-18-01 study related activities, are reconfirmed to be eligible and have signed informed consent to participate.
Who cannot join
- Subjects who, in the opinion of the investigator, have demonstrated significant non-compliance with STX-015-18-01 study procedures.
- Subjects who were unblinded to their treatment in STX-015-18-01 study.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Sollis Clinical Study Site 12
Bloomington, Illinois, 61704
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 42
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, 26506
Sollis Clinical Study Site 37
Overland Park, Kansas, 66210
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, 14618
Sollis Clinical Study Site 47
Salt Lake City, Utah, 84107
Sollis Clinical Study Site 17
Shrewsbury, New Jersey, 07702
Sollis Clinical Study Site 40
Tucson, Arizona, 85724
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 Multicenter, Randomized, Follow-up Study to Evaluate the Long-Term Safety of Clonidine Micropellets for the Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults
Long-term follow-up study to evaluate the safety of clonidine micropellets up to 12 months post injection.
- Conditions
- Lumbosacral Radiculopathy
- Being tested
- Long-Term Safety Follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-Term Safety Follow-upDrug
STX-015-18-01 long-term safety follow-up
| Study group | Role | What they receive |
|---|---|---|
| Safety Group | STX-015-18-01 Clonidine Micropellet long-term safety follow-up Receives: Drug: Long-Term Safety Follow-up | |
| Sham Control | STX-015-18-01 Sham control long-term safety follow-up Receives: Drug: Long-Term Safety Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average and Worst NRS from Day 60 post injection to 12 months post injection
Difference in NRS pain scores from Day 60 of STX-015-18-01 to month 12 post injection
Measured: 10 months from completing Day 60 of the STX-015-18-01 study
Secondary outcomes (3)
Incidence of Surgeries
Difference in incidence of surgery, invasive treatment, and prescription medications due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01.
Measured: 12 months from day of injection
Incidence of Invasive treatment received
Difference in incidence of invasive treatment due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01
Measured: 12 months from day of injection
Number of Prescription medications taken
Difference in incidence of invasive treatment due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01
Measured: 12 months from day of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start15 Nov 2018
- Primary completion22 Jan 2021
- Study completion31 May 2021
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sollis Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Gilligan, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776318
- Sponsor's protocol ID
- STX-015-18-02
- Acronym
- RePRIEVE-CM-LT
- Status last verified
- Oct 2023
- First submitted
- 1 Dec 2018
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- 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 Multicenter, Randomized, Follow-up Study to Evaluate the Long-Term Safety of Clonidine Micropellets for the Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults
- ClinicalTrials.gov ID
- NCT03776318
- Acronym / sponsor ID
- RePRIEVE-CM-LT / STX-015-18-02
- Conditions
- Lumbosacral Radiculopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sollis Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 14 Dec 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.
Long-term follow-up study to evaluate the safety of clonidine micropellets up to 12 months post injection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safety Group | – | Drug: Long-Term Safety Follow-upSTX-015-18-01 Clonidine Micropellet long-term safety follow-up |
| Sham Control | – | Drug: Long-Term Safety Follow-upSTX-015-18-01 Sham control long-term safety follow-up |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Comprised of the first 100 subjects who completed all STX-015-18-01 study-related activities, age 18-70, male/female, reconfirmed eligible and signed informed consent.
Key inclusion criteria (1 listed)
- Subject who have successfully completed all STX-015-18-01 study related activities, are reconfirmed to be eligible and have signed informed consent to participate.
Key exclusion criteria (2 listed)
- Subjects who, in the opinion of the investigator, have demonstrated significant non-compliance with STX-015-18-01 study procedures.
- Subjects who were unblinded to their treatment in STX-015-18-01 study.
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 |
|---|---|---|
| Long-Term Safety Follow-upSTX-015-18-01 long-term safety follow-up | Drug | Safety Group, Sham Control |
Primary outcome
Change in Average and Worst NRS from Day 60 post injection to 12 months post injection
Time frame: 10 months from completing Day 60 of the STX-015-18-01 study
Difference in NRS pain scores from Day 60 of STX-015-18-01 to month 12 post injection
3 secondary outcomes
Incidence of Surgeries
Time frame: 12 months from day of injection
Incidence of Invasive treatment received
Time frame: 12 months from day of injection
Number of Prescription medications taken
Time frame: 12 months from day of injection
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
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbosacral Radiculopathy, run by Sollis Therapeutics, Inc. at 25 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?
The sponsor lists 1 inclusion and 2 exclusion criteria. 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 25 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in Average and Worst NRS from Day 60 post injection to 12 months post injection (time frame: 10 months from completing Day 60 of the STX-015-18-01 study). 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.