AbobotulinumtoxinA for Chronic Exertional Compartment Syndrome

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Emory Hawks Sports Medicine Center, Brookhaven, GA
Chronic Exertional Compartment Syndrome+3 More
AbobotulinumtoxinA - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions

  • Chronic Exertional Compartment Syndrome
  • Compartment syndromes

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Baseline, 5 weeks and 3 months

Baseline and 3 months
Absolute change from baseline in the Visual Analog Scale (VAS) at 3 months following treatment
Baseline and 5 weeks
Absolute change from baseline in the Visual Analog Scale (VAS) at 5 weeks following treatment
Month 3
Absolute and Relative change from baseline in the Ankle Range of Motion (Ankle ROM) using a goniometer
Absolute and Relative change from baseline in the Goal Attainment Scaling (GAS)
Absolute and Relative change from baseline in the Manual Muscle Testing (MMT)
Absolute and Relative change from baseline in the Patient-Reported Outcomes from the University of Wisconsin Running Injury and Recovery Index (UWRI).
Absolute and Relative change from baseline in the Single Assessment Numerical Evaluation (SANE)
Absolute and Relative change from baseline in the Ultrasound shear wave elastography measure: stiffness in kilopascals (kPa)
Absolute and Relative change from baseline in the Ultrasound shear wave shear wave velocity (m/s) (SWE)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

AbobotulinumtoxinA
1%Intra-abdominal haemorrhage
1%Ureterolithiasis
1%Abdominoplasty
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%.

Trial Design

2 Treatment Groups

Treatment Group
1 of 2
Control Group
1 of 2
Experimental Treatment
Non-Treatment Group

42 Total Participants · 2 Treatment Groups

Primary Treatment: AbobotulinumtoxinA · Has Placebo Group · Phase 4

Treatment Group
Drug
Experimental Group · 1 Intervention: AbobotulinumtoxinA · Intervention Types: Drug
Control Group
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AbobotulinumtoxinA
2019
Completed Phase 4
~490

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 5 weeks and 3 months
Closest Location: Emory Hawks Sports Medicine Center · Brookhaven, GA
Photo of georgia 1Photo of georgia 2Photo of georgia 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Chronic Exertional Compartment Syndrome
0 CompletedClinical Trials

Who is running the clinical trial?

IpsenIndustry Sponsor
319 Previous Clinical Trials
68,831 Total Patients Enrolled
Emory UniversityLead Sponsor
1,494 Previous Clinical Trials
2,665,921 Total Patients Enrolled
Lee KneerPrincipal InvestigatorEmory University

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Group providing normative values for SWE and needle manometry - ICP assessments.
You must be a male or female runner aged 18-65 years.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.