New injection aims to ease stroke-related muscle stiffness
NCT ID NCT03306615
First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This study tests whether an injection of hyaluronidase can reduce muscle stiffness and spasticity in the arm after a stroke. 56 adults with moderate-to-severe stiffness will receive either the study drug or a placebo, and later switch to the other option. The goal is to improve range of motion and arm function.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 56 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2021
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Johns Hopkins School of Medicine
Baltimore, Maryland, 21231, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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