Peripheral Modulation of Muscle Stiffness and Spasticity

NCT03306615 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IRB00273264
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscle Spasticity

Keywords

Muscle Stiffness; Muscle Spasticity; Stroke; Cerebral Palsy; Hyperreflexia

Outcome Measures

Primary Outcomes (2)

• Most affected upper limb joint passive range of motion (Cohort 1)

  passive range of motion in most affected joint across the upper limb

  9 weeks

• Most affected upper limb joint passive range of motion (Cohort 2)

  passive range of motion in most affected joint across the upper limb

  15 weeks

Secondary Outcomes (3)

• Total upper limb passive and active range of motion

  15 weeks

• Change in upper limb Fugl-Meyer Assessment Score

  15 weeks

• Change in Wolf-Motor Function Test (WMFT) Score

  15 weeks

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Hyaluronidase plus saline

Drug: Hyaluronidase

Control Arm

PLACEBO COMPARATOR

Normal Saline

Drug: Placebo

Interventions

Hyaluronidase DRUG

HYLENEX recombinant, diluted with 0.9% Sodium Chloride Injection

Also known as: Hylenex

Treatment Arm

Placebo DRUG

0.9% Sodium Chloride Injection

Also known as: Normal saline

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• treatment of spasticity with Botulinum toxin or intrathecal baclofen within the past six months, phenol injections within the past 12 months, or ongoing adjustment of anti-spastic medications;
• other neurologic condition that may affect motor response (e.g., Parkinson's disease, amyotrophic lateral sclerosis (ALS), MS);
• clinically significant cognitive dysfunction with score \<19 on Folstein's Mini Mental Status Examination or depression with score \>10 on the Patient Health Questionnaire-9 (PHQ-9);
• pregnancy;
• known hypersensitivity to hyaluronidase;
• claustrophobia;
• standard contraindications for MRI
• Any condition that will preclude the patient from completing the protocol as determined by the PI

Sponsors & Collaborators

• Johns Hopkins University: lead
• Sheikh Khalifa Stroke Institute: collaborator

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Muscle Spasticity; Stroke; Cerebral Palsy; Reflex, Abnormal

Interventions

Hyaluronoglucosaminidase; Saline Solution

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Damage, Chronic

Intervention Hierarchy (Ancestors)

Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ning Cao, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 11, 2017
• Study Start: October 11, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)