AzTrials
AzTrials

Lumbosacral RadiculopathyPhase 3SERENITY CMNCT05614648

Sciatica Epidural Radiculopathy Experimental New Interventional TherapY Clonidine Micropellet

A Phase 3 study testing Clonidine Micropellets and Tuohy epidural needle in people with Lumbosacral Radiculopathy, run by Sollis Therapeutics, Inc. at 30 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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 and Tuohy epidural needle
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
30 sitesUnited States
Study dates
19 Jun 2023to 30 Mar 2024
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

Who may be able to join

  • Must be between 18 and 70 years of age (inclusive) at time the Informed Consent Form (ICF) is signed.
  • Must have a primary diagnosis of unilateral lumbar and/or lumbosacral radiculopathy defined by all of the following: supported by history, physical examination, and radiologic pathology consistent with a disc protrusion, non-sequestered extrusion, or sequestered fragment, as evidenced by magnetic resonance imaging (MRI), that is consistent with the clinical signs and symptoms of lumbar or lumbosacral radiculopathy.
  • Subject's pain must have a radicular component (radiation into the leg along the L3-S1 [inclusive] dermatomal pattern) and may or may not be associated with additional neuropathic features such as reduced sensory, motor, or deep tendon reflexes.
  • Worst radicular pain symptoms should be confined to a single dermatomal level as confirmed on physical examination (to allow determination of injection level).
  • The NRS leg pain must be ≥4, must extend below the knee and be consistent with one of the dermatomal distributions noted above.
  • Radicular pain symptoms in the current episode must have been present for at least 8 weeks, but not longer than 9 months at the time of Screening.
Show all 17Show fewer
  • Subjects must not have had a significant reduction in the pain in the 1 to 2 weeks before Screening (i.e., pain must not be improving significantly based on the discretion of the Investigator).
  • Baseline 0-10 NRS average pain score localized to at least 1 target location must be ≥6 and ≤9.
  • Subjects must be able to separately distinguish and characterize the contribution of back and leg pain to their overall pain to independently assess the response of each to intervention. Investigators must confirm that subjects can do so based upon pain diagrams and direct questioning.
  • Subjects must have had no significant improvement following a minimum of 8 weeks of the following categories prior to Screening:
  • Mechanical intervention (eg, physical therapy, home exercise program, heat compresses/massage, chiropractic treatment), and
  • Over-the-counter analgesics (non-steroidal anti-inflammatory drugs, topical patches/creams/gels/ointments).
  • Subjects of childbearing potential must have a negative (serum) pregnancy test at Screening and a negative urine pregnancy test within 24 hours before the injection procedure and must commit to either abstain continuously from sexual intercourse or to use, at the Investigator's discretion, highly effective birth control during the study period.
  • Must sign an ICF indicating that they understand the purpose and any risks associated with the procedure required for the study and is willing to participate in the study to completion.
  • Must be willing and able to adhere to the prohibitions and restrictions specified in the protocol.
  • Must be able to read, write, understand, and complete study-related tasks, and adequately communicate regularly with the site.
  • Must have an email address and access to the internet from an electronic device in order to complete daily EDQ information.

Who cannot join

  • Subject has significant pain unrelated to the lumbar or lumbosacral radiculopathy (eg, knee pain, hip pain, or rib pain) that, in the Investigator's opinion, could require chronic analgesic treatment and interfere with the assessment of IP therapeutic effect.
  • Subject has radiological findings or presenting features such as severe motor weakness (with or without reduced deep tendon reflexes) and is a candidate for surgical referral (i.e., progressive neurologic deficit or cauda equina syndrome).
  • Subject has evidence of pathology on MRI (obtained during the current episode of pain) that may result in pain unlikely to be addressed by the IP, including but not limited to the following:
  • Symptomatic (eg, neurogenic claudication) radiographically confirmed central stenosis at any level or diffuse spine pathology.
  • Non-inflammatory or bony lateral recess or foraminal stenosis such as that caused by facet hypertrophy or osteophytes that is a significant contributor to the current episode of pain.
  • Spondylolisthesis > 3 mm at the level of the involved dermatome.
Show all 42Show fewer
  • Evidence of a lumbar vertebral compression fracture, synovial cyst, lumbar epidural lipomatosis, or extraforaminal pathology.
  • Subject has a history of, or current diagnosis of, fibromyalgia.
  • Subject has a history of lumbar surgery and/or intradiscal interventions (including discography).
  • Subject has an active infection (eg, fever or other objective evidence of an infection within 7 days of the planned injection) or any skin condition visible at the injection site at time of Screening.
  • Subject has evidence of a coagulation abnormality or history of abnormal bleeding or is on anticoagulation therapy at time of Screening.
  • Subject has current untreated or clinically significant anxiety and/or depression as defined by the following:
  • Beck Anxiety Inventory® (BAI®) score ≥29 or,
  • Beck Depression Inventory-2® (BDI®) score ≥31.
  • Changes in medications administered for treatment of depression or anxiety within the 30 days before Screening. Note: If a subject is taking antidepressant or anti-anxiety medication, either for the treatment of depression/anxiety or as an analgesic adjunct, the subject must agree to maintain a stable dose (no change in dosage) for the first 3 months of the study.
  • Subject is planning to receive a spinal injection or spine procedure while participating in this study, unless this procedure can be postponed until study completion.
  • Subject has received an ESI, nerve block, or other similar procedure in the lumbosacral area performed during the 8 weeks prior to Screening.
  • Subject is receiving or has received the following medications prohibited in this study:
  • Short-acting opioids taken as needed (PRN) less than 4 days a week (hydrocodone, oxycodone, tramadol, etc.) within 14 days prior to Screening.
  • Long-acting opioids or short-acting opioids taken regularly, i.e., more than 4 days a week within 30 days prior to Screening.
  • Anticonvulsants for treatment of radicular leg pain if the dose has changed in the 30 days prior to Screening or the subject is unable to maintain a stable dose for the first 3 months of the study.
  • Systemic corticosteroids within the 30 days prior to Screening.
  • Central alpha-agents, including clonidine-containing medication or dexmedetomidine within 30 days before Screening.
  • Subject has a history of treatment, or has been recommended for treatment, of alcohol or drug use disorder treatment within the year prior to Screening.
  • Subject has a known or suspected allergy, hypersensitivity, or intolerance to any of the following:
  • Clonidine/clonidine hydrochloride.
  • Polylactic acid (found in products such as Lupron Depot®, Atridox®, some types of dermal fillers, and some types of sutures).
  • Radiographic contrast agents or any other medications to be used during the procedure.
  • Subject has recent (within previous 8 weeks) symptomatic hypotension, orthostatic hypotension, or bradycardia.
  • Subject has a Body Mass Index (BMI) or a body habitus that, in the Investigator's judgment, would require a needle longer than a 3.5-inch Tuohy needle.
  • Subject has participated in a clinical trial of an investigational drug or device within 30 days of Screening.
  • Subject has previously participated in a clinical trial sponsored by Sollis Therapeutics (including Protocol Number STX-015-18-01 and Protocol Number STX-015-18-02).
  • Subject has any medical condition that, in the Investigator's opinion, could adversely impact study participation or safety, require chronic analgesic treatment, or interfere with the pain assessments (eg, painful neuropathy, rheumatologic disorder, etc.).
  • Subject has worker's compensation benefits and/or is involved in any litigation related to his/her radicular pain.
  • Subject is currently pregnant or breast feeding, planning to become pregnant or, if of childbearing potential, is unwilling to have a pregnancy test administered or use appropriate, highly effective contraception.
  • Subject is unable or unwilling to undergo MRI examinations.
  • Subject is unable to adequately rate his/her pain in the EDQ.
  • Presence of active kidney disease, as evidenced by an estimated glomerular filtration rate of less than 60 mL/min/1.73m2 utilizing the Chronic Kidney Disease Epidemiology Collaboration equation.
  • Subjects will be excluded from randomization if they have any of the following during the 7-day Baseline Period:
  • Two or more ratings of NRS Average Leg Pain and/or Back Pain > 9 (showing severe pain),
  • Two or more ratings of NRS Average Leg Pain and/or Back Pain ≥ 9 AND ≤ 3 (showing inconsistent pain).
  • Employees of Sollis Therapeutics, Novotech Health Holdings, or study site personnel directly affiliated with this study, and their immediate family members. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • Injury Care Research (site 130)

    Boise, Idaho, 83713

  • Clinical Trials of South Carolina (site 114)

    Charleston, South Carolina, 29406

  • St. Louis Pain Consultants (site 134)

    Chesterfield, Missouri, 63017

  • Brigham and Women's Hospital (site 129)

    Chestnut Hill, Massachusetts, 02467

  • Wake Forest Pain & Spine Specialists (site 112)

    Clemmons, North Carolina, 27012

  • Cleveland Clinic (site 121)

    Cleveland, Ohio, 44106

  • University Hospitals (site 131)

    Cleveland, Ohio, 44106

  • HRMD Research (site 102)

    Dallas, Texas, 75240

  • UT Southwestern (site 140)

    Dallas, Texas, 75390

  • Physicians' Research Options (site 122)

    Draper, Utah, 84020

  • Clinical Investigations LLC (site 103)

    Edmond, Oklahoma, 73013

  • Pacific Sports and Spine, LLC (site 133)

    Eugene, Oregon, 97401

  • NCP Clinical Research (site 141)

    Houston, Texas, 77008

  • University of Kansas Medical Center (site 137)

    Kansas City, Kansas, 66160

  • UCSD (site 124)

    La Jolla, California, 92037

  • Mocasa Wellness Center (site 119)

    Miami, Florida, 33135

  • AMPM Research Clinic (site 106)

    Miami, Florida, 33169

  • Nurovations/Napa Pain Institute (site 107)

    Napa, California, 94558

  • Neuroscience Research Center (site 105)

    Overland Park, Kansas, 66210

  • CenExel JBR Clinical Research (site 113)

    Salt Lake City, Utah, 84107

  • Texas Pain Consultant Associates (site 110)

    Sugar Land, Texas, 77479

  • Florida Pain Relief Group (site 126)

    Tampa, Florida, 33603

  • ARH Research, LLC (site 108)

    The Woodlands, Texas, 77382

  • Pima Pain Center (site 125)

    Tucson, Arizona, 85711

  • University of Arizona/Banner (site 116)

    Tucson, Arizona, 85711

  • Quality of Life Medical & Research Centers, LLC (site 127)

    Tucson, Arizona, 85712

  • International Spine, Pain & Performance Center (site 118)

    Washington D.C., District of Columbia, 22205

  • Space City Pain (site 135)

    Webster, Texas, 77598

  • The Center for Clinical Research (site 101)

    Winston-Salem, North Carolina, 27103

  • Conquest Research (site 142)

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Phase 3, Prospective, Multicenter, Randomized, Double-blind, Sham-controlled Study of the Efficacy and Safety of STX-015 in the Treatment of Pain Associated With Lumbosacral Radiculopathy

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.

Being tested
Clonidine Micropellets, Tuohy epidural needle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clonidine MicropelletsDrug

    0.975 mg clonidine hydrochloride as 3 micropellets administered in one injection

  • Tuohy epidural needleDevice

    18-gauge Tuohy epidural needle using a custom-built injector

Study groups in NCT05614648
Study groupRoleWhat they receive
Clonidine Micropellets InjectionActive comparatorClonidine Micropellets single dose injection into the lumbar epidural space
Receives: Drug: Clonidine Micropellets; Device: Tuohy epidural needle
Sham InsertionSham comparatorSham Control non-epidural needle placement
Receives: Device: Tuohy epidural needle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary efficacy: Pain Intensity Difference (PID) for the average pain Numeric Rating Scale (NRS) from baseline to D90 in lumbosacral radiculopathy.

    Difference in average pain score, using a scale of 0-10 with 0 no pain and 10 worst possible pain, from baseline to day 90.

    Measured: Baseline to day 90

  2. Incidence of Treatment-Emergent Adverse Events.

    Difference in incidence of adverse events and treatment due to radicular leg pain from Baseline to day 90 post injection based on physical examination findings and vital signs measurements.

    Measured: Baseline to day 90

  3. Incidence of symptomatic hypotension as an adverse event of special interest.

    Difference in incidence defined as low blood pressure associated with subject-reported symptoms of dizziness, lightheadedness, syncope, blurred vision, or nausea.

    Measured: Baseline to day 90

Secondary outcomes (4)

  1. 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 month12

  2. Difference in Rescue medication consumption.

    Consumption from baseline through day 30

    Measured: Baseline to month12

  3. Change in Average and Worst NRS from Day 90 post injection to 12 months post injection.

    Difference in NRS pain scores from Day 90 to month 12 post injection.

    Measured: from Day 90 to month 12 post injection

  4. Percent of subjects with significant improvement in pain.

    30 percent improvement in pain from baseline to day 90.

    Measured: Baseline to day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2022
  2. Study start19 Jun 2023
  3. Primary completion18 Mar 2024
  4. Study completion30 Mar 2024

Why it stopped: Loss of funding- Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.

Resources

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05614648
Sponsor's protocol ID
STX-015-23-01
Acronym
SERENITY CM
Status last verified
Apr 2024
First submitted
27 Oct 2022
Last updated
25 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Clonidine Micropellets and Tuohy epidural needle in people with Lumbosacral Radiculopathy, run by Sollis Therapeutics, Inc. at 30 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 17 inclusion and 42 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: stopped early, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 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 was stopped early (reason given: Loss of funding- Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.). Results are not available in the source record.

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?

Primary efficacy: Pain Intensity Difference (PID) for the average pain Numeric Rating Scale (NRS) from baseline to D90 in lumbosacral radiculopathy. (time frame: Baseline to day 90). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05614648.

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 25 Apr 2024; AzTrials last refreshed its copy on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in