Chronic Exertional Compartment Syndrome (CECS) Treated With Abobotulinumtoxin A

PHASE4CompletedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

April 25, 2024

Primary Completion Date

August 13, 2025

Study Completion Date

August 13, 2025

Conditions
Compartment Syndrome of Leg
Interventions
DRUG

AbobotulinumtoxinA

Participants randomized to receive aboBoNTA will receive a maximum of 200 units of aboBoNTA distributed across the following muscles: Targeted muscles will be selected from the Anterior (A) and Lateral (L) Compartments. They include (A) Tibialis Anterior (60 units), Extensor Digitorum Longus (20) and Extensor Hallucis Longus (20); (L) Fibularis Brevis (50) and Fibularis Longus (50). Tibialis Anterior (60U); Extensor Digitorum Longus (20); Extensor Halluces Longus (20); Fibularis Brevis (50), and; Fibularis longus (50). Treatment distribution across targeted muscles will be based on clinical presentation including muscle compartment(s) involvement as determined by ICP testing and SWE imaging.

DRUG

Placebo

Participants randomized into the normal saline group will receive injections distributed across the following muscles: Targeted muscles will be selected from the Anterior (A) and Lateral (L) Compartments. They include (A) Tibialis Anterior, Extensor Digitorum Longus, and Extensor Hallucis Longus; (L) Fibularis Brevis and Fibularis Longus. Tibialis Anterior; Extensor Digitorum Longus; Extensor Halluces Longus; Fibularis Brevis, and; Fibularis longus. Treatment distribution across targeted muscles will be based on clinical presentation including muscle compartment(s) involvement as determined by ICP testing.

Trial Locations (2)

30329

Emory Hawks Sports Medicine Center, Brookhaven

30338

Emory Sports Medicine-Dunwoody, Atlanta

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Ipsen

INDUSTRY

lead

Emory University

OTHER