3
Participants
Start Date
April 25, 2024
Primary Completion Date
August 13, 2025
Study Completion Date
August 13, 2025
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.
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.
Emory Hawks Sports Medicine Center, Brookhaven
Emory Sports Medicine-Dunwoody, Atlanta
Collaborators (1)
Ipsen
INDUSTRY
Emory University
OTHER