What side effects are associated with this type of intervention?

Common treatments for muscle spasms include medications such as muscle relaxants, anti-inflammatory drugs, and localized injections like hyaluronidase. Muscle relaxants can cause side effects such as drowsiness, dizziness, and dependency with long-term use. Anti-inflammatory drugs may lead to gastrointestinal issues, including ulcers and bleeding. Localized injections, such as hyaluronidase, can cause localized pain, swelling, and potential allergic reactions. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

FDA-approved treatments for muscle spasms typically include medications such as muscle relaxants (e.g., baclofen, cyclobenzaprine, and tizanidine) and antispasmodics (e.g., dantrolene). These drugs work through various mechanisms, such as central nervous system depression or direct action on skeletal muscles, to alleviate muscle stiffness and spasms. While human recombinant hyaluronidase, which breaks down hyaluronic acid to reduce tissue viscosity and muscle stiffness, is being studied, there are no specific FDA approvals for this exact mechanism in the treatment of muscle spasms. However, the general approach of reducing muscle stiffness is a common therapeutic target in existing treatments.

What other types of research exist?

Promising alternatives to Human Recombinant Hyaluronidase for treating muscle spasms include: <ol> <li>Hydrocortisone: It has been shown to mitigate muscle atrophy and inflammation, potentially improving muscle mass and strength.</li> <li>β-Hydroxy-β-Methylbutyrate (HMB): This supplement enhances calcium release in muscle cells and improves muscle viability and proliferation, which may help in reducing muscle stiffness and spasms.</li> <li></li> </ol> TMB-8: Although primarily studied for its effects on malignant hyperthermia, it is a calcium antagonist that affects muscle contracture responses and could be explored for muscle spasm treatment.

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Enzyme

Hyaluronidase for Muscle Spasms

Phase 2

Recruiting

Led By Pablo Celnik, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Other neurologic condition that may affect motor response (e.g., Parkinson's disease, ALS, MS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 weeks

Summary

This trial tests if using a special enzyme can help people who have stiff arm muscles after a stroke. The enzyme works by reducing substances that cause muscle tightness, which may improve arm movement and strength. This new therapy aims to reduce muscle stiffness by breaking down certain substances in the muscles.

Who is the study for?

This trial is for individuals who had a stroke 6-120 months ago and are experiencing moderate to severe muscle stiffness in their upper limb. They must be able to consent, undergo MRI scans, and follow the study's procedures. Excluded are those with recent spasticity treatments, other neurological conditions like Parkinson's or ALS, significant cognitive issues or depression, pregnancy, hyaluronidase allergy, claustrophobia or MRI contraindications.

What is being tested?

The trial tests human recombinant hyaluronidase injections against saline (placebo) in reducing muscle stiffness post-stroke. It's double-blind and placebo-controlled with two phases ensuring all participants receive treatment at some point over nine weeks with seven visits including MRIs before the first injection but not after the second.

What are the potential side effects?

Potential side effects may include allergic reactions to hyaluronidase such as swelling or itching at the injection site. Since it’s a blinded study involving placebos as well, distinguishing between actual drug side effects from placebo will be part of the evaluation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can't fully move at least two parts of my arm on one side.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a neurological condition like Parkinson's, ALS, or MS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Most affected upper limb joint passive range of motion

Secondary study objectives

Change in Wolf-Motor Function Test (WMFT) Score

Change in upper limb Fugl-Meyer Assessment Score

Total upper limb passive and active range of motion

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment ArmExperimental Treatment1 Intervention

Hyaluronidase plus saline

Group II: Control ArmPlacebo Group1 Intervention

Normal Saline

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hyaluronidase

2007

Completed Phase 4

~370

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for muscle spasms include human recombinant hyaluronidase, which breaks down hyaluronic acid to reduce tissue viscosity and muscle stiffness, and botulinum toxin A (BoNT-A), which inhibits acetylcholine release at the neuromuscular junction to relax muscles. Low-Intensity Focused Ultrasound (LIFU) also helps by increasing the expression of neuronal K-Cl cotransporters, reducing muscle hyperactivity. These treatments are important for muscle spasm patients as they address the root causes of muscle stiffness and hyperactivity, offering relief and enhancing mobility and quality of life.

Low-Intensity Focused Ultrasound Alleviates Spasticity and Increases Expression of the Neuronal K-Cl Cotransporter in the L4-L5 Sections of Rats Following Spinal Cord Injury.Effects of muscle relaxants on ischaemia damage in skeletal muscle.Identification of the optimal dose and calpain system regulation of tetramethylpyrazine on the prevention of skeletal muscle atrophy in hindlimb unloading rats.