AbobotulinumtoxinA for Chronic Exertional Compartment Syndrome
Phase-Based Progress Estimates
Emory Hawks Sports Medicine Center, Brookhaven, GA
Chronic Exertional Compartment Syndrome+3 More
AbobotulinumtoxinA - Drug
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What conditions do you have?
What conditions do you have?
Chronic Exertional Compartment Syndrome (CECS) is a painful condition affecting runners and it is caused by a reversible increase in pressure within a closed compartment in the leg. Currently, to diagnose CECS, a large needle is placed into the muscle to measure pressure, which is invasive and painful. After diagnosis, the gold standard of treatment is surgery, which is also invasive, involves a prolonged return to play, and has a significant number of treatment failures. A growing literature has suggested alternative methods to both diagnosis and treatment that include the use of ultrasound to investigate muscle stiffness with shear wave elastography (SWE), and treatment with botulinum toxin injection into the muscle.
The investigators propose a single-site randomized clinical trial to investigate the use of abobotulinumtoxinA in the treatment of CECS. Researchers also look to develop a non-invasive method for the diagnosis of CECS using SWE. To the researchers' knowledge, this is the first randomized study investigating the medication to treat this cause.
The study will take place at Emory's outpatient sports medicine clinic. Potential participants will primarily be identified and recruited from the departments of Physical Medicine and Rehabilitation, Orthopedics, Physical Therapy, and Sports medicine as a part of regular clinical care. Participants will be included in the randomized portion of the study if they meet the previously established diagnostic criteria for CECS with compartmental pressure testing.
This would be a landmark study to provide evidence for the use of an abobotulinumtoxinA in the treatment of CECS, leading to the potential avoidance of a surgical procedure. It could also change the means of diagnosis without the use of painful and invasive needle pressure testing that would provide patients and athletes with ease of care.
Chronic Exertional Compartment Syndrome
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This is further along than 93% of similar trials
Other trials for Chronic Exertional Compartment Syndrome
This histogram enumerates side effects from a completed 2019 Phase 4 trial (NCT03687736) in the AbobotulinumtoxinA ARM group. Side effects include: Intra-abdominal haemorrhage with 1%, Ureterolithiasis with 1%, Abdominoplasty with 1%.
2 Treatment Groups
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42 Total Participants · 2 Treatment Groups
Primary Treatment: AbobotulinumtoxinA · Has Placebo Group · Phase 4
Experimental Group · 1 Intervention: AbobotulinumtoxinA · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4
Screening: ~3 weeks
Reporting: baseline, 5 weeks and 3 months
Closest Location: Emory Hawks Sports Medicine Center · Brookhaven, GA
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.