A Phase 2 interventional study of Hyaluronidase and Placebo in Muscle Spasticity, sponsored by Johns Hopkins University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Treatment
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.
621 studies on the registry are indexed under Muscle Spasticity; 127 are open to participants now.
This study's planned enrollment of 56 is above the median of 36 across 472 interventional studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hyaluronidase plus saline
Drug: Hyaluronidase
Normal Saline
Drug: Placebo
HYLENEX recombinant, diluted with 0.9% Sodium Chloride Injection
Also known as: Hylenex
0.9% Sodium Chloride Injection
Also known as: Normal saline
Most affected upper limb joint passive range of motion (Cohort 1)
passive range of motion in most affected joint across the upper limb
Time frame: 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
Time frame: 15 weeks
Total upper limb passive and active range of motion
passive and active range of motion in shoulder, elbow and forearm joints
Time frame: 15 weeks
Change in upper limb Fugl-Meyer Assessment Score
measures motor impairment in the affected upper limb, Score range is 0-66, and a higher score indicates a better outcome
Time frame: 15 weeks
Change in Wolf-Motor Function Test (WMFT) Score
Measures upper extremity function following stroke, Includes 6 items, with a 0-5 score range for each item, and a higher score indicates a better outcome
Time frame: 15 weeks
Ran from Oct 2021 to primary completion in Jun 2026, 56 months.
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This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hyaluronoglucosaminidase