What side effects are associated with this type of intervention?

Common treatments for Sciatica include medications such as alpha-2 adrenergic agonists like clonidine. Known side effects of these treatments can include hypotension (low blood pressure), bradycardia (slow heart rate), dry mouth, sedation, and dizziness. These side effects are due to the medication's action on the central nervous system and its ability to reduce sympathetic outflow.

What prior FDA approvals exist?

There is limited information on FDA approvals specifically for alpha-2 adrenergic agonists like clonidine micropellet for the treatment of sciatica. Generally, treatments for sciatica include nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, anticonvulsants, and antidepressants. Epidural steroid injections are also commonly used. While clonidine and other alpha-2 adrenergic agonists are being studied for their potential in pain management, they are not yet widely approved for sciatica specifically.

What other types of research exist?

Promising novel alternatives to Clonidine Micropellet for Sciatica patients include: 1) Gabapentin, which has shown efficacy in managing neuropathic pain; 2) Pregabalin, another antiepileptic drug effective for neuropathic pain; 3) Duloxetine, a serotonin and norepinephrine reuptake inhibitor (SNRI) that has been effective in treating chronic pain conditions; and 4) Low-dose Ketamine, which has demonstrated opioid-sparing effects and efficacy in pain management. These alternatives offer different mechanisms of action and have been supported by recent studies.

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Alpha-2 Adrenergic Agonist

Clonidine Injection for Sciatica (SERENITY CM Trial)

Phase 3

Waitlist Available

Research Sponsored by Sollis Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to month12

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions at the injection site such as soreness or infection, lower blood pressure, dizziness due to hypotension, slow heart rate (bradycardia), and possibly other systemic effects related to clonidine's action on nerve pathways.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to month12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to month12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events.

Hypotension

Pain

Secondary study objectives

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

Change in Oswestry Disability Index (ODI) score

Pharmaceutical Preparations

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Clonidine Micropellets InjectionActive Control2 Interventions

Clonidine Micropellets single dose injection into the lumbar epidural space

Group II: Sham InsertionPlacebo Group1 Intervention

Sham Control non-epidural needle placement

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Sciatica treatments often target pain relief and inflammation reduction. Alpha-2 adrenergic agonists, such as clonidine, work by stimulating alpha-2 receptors in the central nervous system, which inhibits the release of norepinephrine and reduces pain signals. This mechanism is particularly relevant for Sciatica patients as it can provide significant pain relief without the sedative effects of other medications. Other common treatments include NSAIDs, which reduce inflammation and pain by inhibiting cyclooxygenase enzymes, and physical therapies that improve mobility and reduce nerve compression. Understanding these mechanisms helps patients and doctors choose the most effective and appropriate treatment options for managing Sciatica symptoms.