Clonidine Injection for Sciatica

(SERENITY CM Trial)

No longer recruiting at 40 trial locations

Overseen By Mehul Desai, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sollis Therapeutics, Inc.

Must not be taking: Opioids, Anticonvulsants, Corticosteroids, Clonidine

Disqualifiers: Fibromyalgia, Lumbar surgery, Anxiety, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether clonidine micropellets can safely and effectively reduce pain from sciatica. Participants will receive a single injection of either clonidine micropellets or a sham injection to evaluate its effectiveness in relieving low back and leg pain. Individuals with sciatica-related back and leg pain lasting at least 8 weeks but no more than 9 months, and whose pain hasn't significantly improved with other treatments, might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before participating. You must not have taken short-acting opioids regularly, long-acting opioids, anticonvulsants with dose changes, systemic corticosteroids, or central alpha-agents like clonidine within specific time frames before screening. If you are on antidepressants or anti-anxiety medications, you must maintain a stable dose for the first 3 months of the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that clonidine micropellets are generally safe for people. One study found that these micropellets release clonidine slowly and safely over time. This allows the medicine to remain in the body longer, helping to manage pain without causing serious side effects. Although every treatment can have some side effects, data so far suggests that clonidine micropellets are well-tolerated. For those considering joining a trial, this could mean fewer concerns about unexpected problems. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for sciatica?

Clonidine Micropellets are unique because they offer a new way to manage sciatica by directly targeting the lumbar epidural space with a single dose injection. Unlike standard treatments such as oral pain relievers or physical therapy, this method delivers clonidine right where the pain originates, potentially providing faster relief. Researchers are excited about this treatment because it could reduce reliance on systemic medications, leading to fewer side effects, and offer a quicker, more targeted approach to pain management.

What evidence suggests that clonidine micropellets might be an effective treatment for sciatica?

Research has shown that clonidine micropellets, which participants in this trial may receive, might help treat sciatica. Studies have found that clonidine can relieve nerve pain and reduce inflammation, potentially easing the pain caused by irritated nerves in sciatica. In some studies, patients experienced pain relief within a day after receiving a clonidine micropellet injection. These results suggest that clonidine micropellets could offer a promising new way to manage sciatica pain. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

Adults aged 18-70 with sciatica pain (leg pain ≥4, extending below the knee) for at least 8 weeks but less than 9 months, due to a specific type of lumbar disc issue confirmed by MRI. Participants must not have had recent pain relief and should be able to distinguish back from leg pain. Pregnant women or those planning pregnancy are excluded, as well as individuals with certain medical conditions or treatments that could affect study results.

Inclusion Criteria

I can tell the difference between my back pain and leg pain.

Subjects must not have had a significant reduction in pain in the 1 to 2 weeks before Screening.

I have been diagnosed with a specific type of lower back and leg pain, confirmed by an MRI.

Exclusion Criteria

I have had recent issues with low blood pressure or slow heart rate.

I have active kidney disease.

Subject has a known or suspected allergy, hypersensitivity, or intolerance to specific substances.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of either clonidine micropellet or sham injection for the treatment of low back and leg pain from sciatica

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits (in-person and virtual) over 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Clonidine Micropellets
• Tuohy Epidural Needle

Trial Overview The trial is testing clonidine micropellets delivered via a single epidural injection using a Tuohy needle to treat low back and leg pain caused by sciatica. The effectiveness of this new medication will be compared against a sham injection in participants.

How Is the Trial Designed?

Group I: Clonidine Micropellets Injection Active Control 2 Interventions

Clonidine Micropellets single dose injection into the lumbar epidural space

Group II: Sham Insertion Placebo Group 1 Intervention

Sham Control non-epidural needle placement

Who Is Running the Clinical Trial?

Sollis Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

320+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03727100?cond=%22Radiculopathy%22&intr=%22Sympatholytics%22&viewType=Table&rank=2

Treatment of Pain Associated With Lumbosacral ... This study will evaluate the safety and effectiveness of a new pain medication in development, clonidine micropellet. Participants will receive a single ...

2. papers.ssrn.com papers.ssrn.com/sol3/papers.cfm?abstract_id=3546125

Safety and Efficacy of Novel Epidural Clonidine ... Clonidine's anti-neuropathic and anti-inflammatory effects could treat the radicular pain process at the nerve root resulting in long term pain ...

3. withpower.com withpower.com/trial/phase-3-lumbosacral-radiculopathy-3-2023-e205a

Clonidine Injection for Sciatica · Info for Participants This trial is testing a new pain medication called clonidine micropellet, given as a single injection, to help people with low back and leg pain from sciatica.

4. scitechjournals.com scitechjournals.com/articles/epidural-clonidine-micropellets-for-lumbosacral-radiculopathy-a-novel-approach-to-pain-management.pdf

Epidural Clonidine Micropellets for Lumbosacral ... Our study demonstrated onset of pain relief within 1 day of injection of clonidine micropellets in a population with baseline symptom duration ...

5. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT03727100/

Trial | NCT03727100 This study will evaluate the safety and effectiveness of a new pain medication in development, clonidine micropellet. Participants will receive a single ...

6. ctv.veeva.com ctv.veeva.com/study/sciatica-epidural-radiculopathy-experimental-new-interventional-therapy-clonidine-micropellet

Sciatica Epidural Radiculopathy Experimental New ... This study will evaluate the safety and effectiveness of a new pain medication in development, clonidine micropellet.