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Neurotoxin

Abobotulinumtoxin A for Chronic Exertional Compartment Syndrome (CECS Trial)

Phase 4
Recruiting
Led By Lee Kneer
Research Sponsored by Emory University
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, 5 weeks and 3 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial looks at the use of botulinum toxin to treat chronic exertional compartment syndrome, a painful condition that affects runners. The goal is to develop a non-invasive method for the diagnosis of CECS using shear wave elastography.

Who is the study for?
This trial is for adult runners aged 18-65 who have been diagnosed with Chronic Exertional Compartment Syndrome (CECS), a painful leg condition. They must meet specific diagnostic criteria with compartment pressure testing to participate.
What is being tested?
The study tests AbobotulinumtoxinA, a potential non-surgical treatment for CECS, against a placebo. It also aims to develop a non-invasive diagnosis method using ultrasound shear wave elastography (SWE).
What are the potential side effects?
While not explicitly stated, side effects of AbobotulinumtoxinA may include muscle weakness near the injection site, bruising or pain at the injection site, and less commonly systemic effects like flu-like symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 5 weeks and 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 5 weeks and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absolute change from baseline in the Visual Analog Scale (VAS) at 3 months following treatment
Secondary study objectives
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)
+5 more

Side effects data

From 2019 Phase 4 trial • 120 Patients • NCT03687736
1%
Abdominoplasty
1%
Intra-abdominal haemorrhage
1%
Ureterolithiasis
100%
80%
60%
40%
20%
0%
Study treatment Arm
AbobotulinumtoxinA

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment GroupExperimental Treatment1 Intervention
AbobotulinumtoxinA
Group II: Control GroupPlacebo Group1 Intervention
Normal Saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AbobotulinumtoxinA
2019
Completed Phase 4
~490

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,708 Previous Clinical Trials
2,607,442 Total Patients Enrolled
IpsenIndustry Sponsor
352 Previous Clinical Trials
74,348 Total Patients Enrolled
Lee KneerPrincipal InvestigatorEmory University

Media Library

AbobotulinumtoxinA (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT05466539 — Phase 4
Compartment Syndrome Research Study Groups: Treatment Group, Control Group
Compartment Syndrome Clinical Trial 2023: AbobotulinumtoxinA Highlights & Side Effects. Trial Name: NCT05466539 — Phase 4
AbobotulinumtoxinA (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05466539 — Phase 4
~18 spots leftby Jul 2025