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New injection aims to ease stroke-related muscle stiffness

NCT ID NCT03306615

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • 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.