Peripheral Modulation of Muscle Stiffness and Spasticity (also called Muscle Stiffness) is a cross-over trial of hyaluronidase to reverse upper limb muscle stiffness in patients who have suffered neurologic injury (stroke, spinal cord injury, etc.). Participants will be injected with hyaluronidase, which is an enzyme that helps break down hyaluronic acid (hyaluronan). A cross-over trial is a type of clinical trial comparing two or more interventions in which the participants, after completing the course of one treatment, are switched to another treatment. For this trial, subjects will be randomized to either the study drug or placebo in phase 1 and will switch to the other treatment in phase 2.
This trial’s investigators hypothesize that excess hyaluronic acid in the extracellular matrix (ECM) contributes to muscle stiffness. Normally, hyaluronic acid provides lubrication for sliding and myofascial force transmission within and between muscles. However, studies have shown that neurologic injury creates a build-up of hyaluronic acid, which may contribute to muscle stiffness by making muscles stick together. This trial proposes that the breaking down of hyaluronic acid (hydrolysis) with the enzyme hyaluronidase in muscles can potentially stop muscle stiffness from progressing to tissue scarring, stiff joints caused by permanent tissue tightening, and, ultimately, disability.
This trial is a single-center, double-blind, randomized, placebo-controlled, cross-over, phase 2 clinical trial. The trial plans to enroll 50 participants. BIOS CTCC will serve as the DCC, and the trial is funded by the Johns Hopkins Sheikh Khalifa Stroke Institute.
ClinicalTrials.gov Identifier: NCT03306615