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Neurotoxin

Abobotulinumtoxin A for Chronic Exertional Compartment Syndrome (CECS Trial)

Phase 4

Waitlist Available

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

CECS Trial 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.

Eligible Conditions

Compartment Syndrome of the Leg

CECS Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 5 weeks and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absolute change from baseline in the Visual Analog Scale (VAS) at 3 months following treatment

Secondary outcome measures

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

Intra-abdominal haemorrhage

Abdominoplasty

Ureterolithiasis

100%

80%

60%

40%

20%

Study treatment Arm

AbobotulinumtoxinA

CECS 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,531 Total Patients Enrolled

IpsenIndustry Sponsor

345 Previous Clinical Trials

73,186 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still being accepted for this experiment?

"Clinicaltrials.gov reports that this trial, which was initially posted on November 1st 2022, is not currently enrolling patients. Nonetheless, there are 1390 other studies actively recruiting participants at the moment."

Answered by AI

What is the safety profile of AbobotulinumtoxinA when used therapeutically?

"AbobotulinumtoxinA has already been approved, giving it a safety rating of 3 according to Power's evaluation scale."

Answered by AI

Is this research open to octogenarian participants?

"Eligible participants of this clinical trial must be over the age of consent, but under 65 years old."

Answered by AI

Are there any eligibility requirements for participating in this research?

"This clinical trial seeks 42 adult males and females, all aged between 18-65 years old, afflicted with chronic exertional compartment syndrome to participate. These participants must meet the standards of Group providing normative values for SWE and needle manometry - ICP assessments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Chronic Exertional Compartment Syndrome (CECS) Treated With Abobotulinumtoxin A

Lee Kneer 2024. "Chronic Exertional Compartment Syndrome (CECS) Treated With Abobotulinumtoxin A". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05466539.