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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 5 weeks and 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 5 weeks and 3 months
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 moreSide effects data
From 2019 Phase 4 trial • 120 Patients • NCT036877361%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group
- Group 2: Control Group
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.