← Back to Search

Alpha-2 Adrenergic Agonist

Clonidine Injection for Sciatica (SERENITY CM Trial)

Phase 3
Recruiting
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

Find a Location

Who is running the clinical trial?

Sollis Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
307 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age criteria of this medical study include individuals who are 45 or older?

"This trial is open to adults aged 18 - 70."

Answered by AI

Where are the sites of implementation for this clinical trial?

"At present, 10 medical centres are actively enrolling patients. Locations include Kansas City, Overland Park and Winston-Salem among others. Choosing a site that is proximal to your residence can help reduce the travel burden of taking part in this trial."

Answered by AI

Is there an ongoing call for participants in this research?

"According to information readily accessible on clinicaltrials.gov, this medical trial is still open for enrollment. It was initially posted by the research team in June of 2023 and has seen its latest update on October 5th of the same year."

Answered by AI

Could you elaborate on the potential hazards of Clonidine Micropellets Injection?

"After assessing all the information available, our team at Power rated Clonidine Micropellets Injection a 3 on safety due to its Phase 3 trial status. This signifies that there is both data supporting efficacy and repeated evidence of safety."

Answered by AI

How many participants are actively taking part in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this research endeavor that was initially shared on June 19th 2023 is presently recruiting individuals. 340 participants are needed at 10 separate medical facilities and the study has recently been updated as of October 5th 2023."

Answered by AI

What is the goal of this clinical endeavor?

"According to Sollis Therapeutics, Inc., the main outcome of this study will be quantifying Adverse Events from Baseline to Day 90. Furthermore, secondary outcomes that will be assessed include a comparison in Rescue medication consumption over 30 days, alteration in Average and Worst NRS pain scores from Day 90 post injection to month 12 post injection, and what percentage of participants experienced an impressive improvement in their pain level (30% or higher)."

Answered by AI

Who has been identified as the best candidates for this trial?

"This clinical trial is looking for 340 individuals aged 18 to 70 who are experiencing sciatica. Applicants must also meet further criteria, such as having a pain score of between 6 and 9 on the 0-10 NRS scale that radiates below the knee in one dermatomal level, not having experienced significant relief from symptoms within two weeks prior to screening, being able to distinguish back and leg pains separately, and have had radicular pain symptoms present for 8-9 months at the time of screening. Furthermore, participants should not have received any mechanical interventions (e.g., physical therapy) before joining this trial."

Answered by AI

Who else is applying?

What site did they apply to?
Sollis Clinical Study Site 18
International Spine, Pain & Performance Center (site 118)
Texas Pain Consultant Associates (site 110)
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I have tried different meds that didn’t help.
PatientReceived 1 prior treatment
~140 spots leftby Dec 2024