Clonidine Injection for Sciatica

(SERENITY CM Trial)

Recruiting at 39 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

17 Participants Needed

Trial Summary

What is the purpose of this trial?

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. The medication aims to reduce pain by blocking pain signals in the nervous system. Clonidine has been used for many years to treat hypertension and chronic pain, with recent interest in topical formulations to limit adverse events.

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.

What data supports the effectiveness of the drug Clonidine Micropellets for treating sciatica?

Research shows that clonidine, when used with other anesthetics, can improve pain relief and stability after spine surgeries. Additionally, clonidine is known to help with chronic pain conditions, suggesting it might be beneficial for sciatica as well. ^{1 2 3 4 5}

Is clonidine injection safe for humans?

Clonidine has been used safely in humans for various conditions, including pain management and spasticity, with some studies showing it does not cause significant sedation or motor impairment. However, it can cause low blood pressure, especially when taken in tablet form, but this effect is minimized with other delivery methods like patches. ^{1 6 7 8 9}

How is the drug Clonidine Micropellets unique for treating sciatica?

Clonidine Micropellets may offer a unique approach to treating sciatica by potentially enhancing the effects of local anesthetics, as clonidine has been shown to improve the quality and duration of pain relief when used with other anesthetics in nerve blocks. This could provide longer-lasting pain relief compared to standard treatments. ^{1 4 5 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Brazil pubmed.ncbi.nlm.nih.gov

[Effects of intramuscular and perineural clonidine on sciatic nerve block with 0.5% ropivacaine.]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The effect of spinal bupivacaine in combination with either epidural clonidine and/or 0.5% bupivacaine administered at the incision site on postoperative outcome in patients undergoing lumbar laminectomy. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

[Alpha 2-adrenergic agonists. Use in chronic pain--a meta-analysis]. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of epidural clonidine on spinal cord blood flow and regional and central hemodynamics in pigs. [2013]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Intrathecal catheter with subcutaneous port for clonidine test bolus injection. A new route and type of treatment for detrusor hyperreflexia in spinal cord-injured patients. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Intrathecal, but not intravenous, clonidine reduces experimental thermal or capsaicin-induced pain and hyperalgesia in normal volunteers. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Intrathecal administration of clonidine suppresses autotomy, a behavioral sign of chronic pain in rats after sciatic nerve section. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Clonidine transdermal system for treatment of spasticity in spinal cord injury. [2013]

9. India pubmed.ncbi.nlm.nih.gov

Evaluation of analgesic effects of intrathecal clonidine along with bupivacaine in cesarean section. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Perineural clonidine does not prolong levobupivacaine 0.5% after sciatic nerve block using the Labat approach in foot and ankle surgery. [2019]

11. India pubmed.ncbi.nlm.nih.gov

Intrathecal clonidine as an adjuvant to hyperbaric bupivacaine in patients undergoing inguinal herniorrhaphy: A randomized double-blinded study. [2022]