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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

SERENITY CM Trial Summary

This trial will test a new pain medication for people with sciatica. Participants will get an injection of either the med or a placebo.

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.Check my eligibility
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.See study design
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.

SERENITY CM Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events.
Hypotension
Pain
Secondary outcome measures
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

SERENITY CM 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

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Who is running the clinical trial?

Sollis Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
307 Total Patients Enrolled
~9 spots leftby Jun 2025
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