Peripheral Modulation of Muscle Stiffness and Spasticity

Who is this study for? Patients with Muscle Spasticity
What treatments are being studied? Hyaluronidase
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a single-center, double-blind, randomized, placebo-controlled, sequential Phase II trial of human recombinant hyaluronidase injections in individuals with post-stroke upper limb muscle stiffness. The investigators will recruit 56 subjects, who will be randomized to receive either the intervention or normal saline injections (first injection), and then the intervention the participants did not receive first (second injection). All individuals will receive the treatment by the end of the study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Ischemic or hemorrhagic stroke 4-180 months prior

• Moderately-severe muscle stiffness

• Lack of full passive and active range of motion in at least 2/4 areas (shoulder, elbow, forearm, wrist) in the hemiparetic upper limb;

• Willingness to have MRI, complete all clinical assessments, and comply with study protocols;

• Ability to give informed consent and HIPPA certifications; and

Locations
United States
Maryland
Johns Hopkins School of Medicine
RECRUITING
Baltimore
Contact Information
Primary
Azin Etemadimanesh, MD
aetemad2@jhmi.edu
410-955-1347
Backup
Robert Nickl, PhD
rnickl1@jhmi.edu
4109551381
Time Frame
Start Date: 2021-10-11
Estimated Completion Date: 2025-11-16
Participants
Target number of participants: 56
Treatments
Experimental: Treatment Arm
Hyaluronidase plus saline
Placebo_comparator: Control Arm
Normal Saline
Authors
Preeti Raghavan, Pablo Celnik
Sponsors
Collaborators: Sheikh Khalifa Stroke Institute
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov