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Clonidine Injection for Sciatica (SERENITY CM Trial)
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.
SERENITY CM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SERENITY CM Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Does the age criteria of this medical study include individuals who are 45 or older?
"This trial is open to adults aged 18 - 70."
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."
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."
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."
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."
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)."
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."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
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