← Back to Search

Enzyme

Hyaluronidase for Muscle Spasms

Phase 2
Recruiting
Led By Ning Cao, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 weeks
Awards & highlights

Study Summary

This trial is testing whether or not human recombinant hyaluronidase injections can help improve muscle stiffness in people who have had a stroke. 50 subjects will be given either the injection or a placebo, and then will be assessed over the course of 9 weeks.

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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total upper limb passive range of motion
Secondary outcome measures
Change in Wolf-Motor Function Test (WMFT) Score
Change in upper limb Fugl-Meyer Assessment Score
Total upper limb 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

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,262 Previous Clinical Trials
14,823,114 Total Patients Enrolled
Ning Cao, MDPrincipal InvestigatorJohns Hopkins University
Pablo Celnik, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Hyaluronidase (Enzyme) Clinical Trial Eligibility Overview. Trial Name: NCT03306615 — Phase 2
Muscle Spasms Research Study Groups: Treatment Arm, Control Arm
Muscle Spasms Clinical Trial 2023: Hyaluronidase Highlights & Side Effects. Trial Name: NCT03306615 — Phase 2
Hyaluronidase (Enzyme) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03306615 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants can join this clinical experiment?

"Affirmative. The information published on clinicaltrials.gov shows that this research is looking for participants at the moment. It was first reported on October 11th 2021, and updated lastly on October 28 2022. A total of 50 people are needed to enrol in two different locations."

Answered by AI

Is enrollment available for this research project?

"As per the details posted on clinicaltrials.gov, this experiment is currently recruiting participants. It was initially broadcasted on October 11th 2021 and revised lastly on October 28th 2022."

Answered by AI

Is this investigation unprecedented in its nature?

"Research into hyaluronidase commenced in 2018 with a clinical trial funded by Hoffmann-La Roche which involved 500 participants. Subsequently, the drug was approved after Phase 3 trials and today there are 6 active research projects spanning 48 cities across 19 nations."

Answered by AI

Has Hyaluronidase obtained authorization from the Federal Drug Administration?

"The safety of hyaluronidase was evaluated as a 2 on the 1-3 scale due to its Phase 2 status, which implies that there is data backing up this drug's security but no evidence yet for efficacy."

Answered by AI

What are the regular applications of Hyaluronidase?

"Hyaluronidase is commonly utilized to enhance the dispersal and absorption of other injected medications. Additionally, this compound can be used in treatment plans for conditions such as hypodermoclysis, parenteral drug administration, and urography."

Answered by AI

What are the primary goals of this research project?

"This scientific experiment, which encompasses a period of around 9 weeks, will assess the Change in upper limb Fugl-Meyer Scale Score. Secondary assessment criteria include Total upper limb active range of motion evaluated through shoulder, elbow and forearm joints; Changes in upper limb Fugl-Meyer Assessment score (0 to 66 scale with higher scores indicative of better results); And alterations observed in Wolf Motor Function Test (WMFT) Scores (6 items scored from 0 to 5 where greater numbers are associated with improved outcomes)."

Answered by AI

Are there any previous investigations that have centered around Hyaluronidase?

"Currently, there are 6 ongoing studies focusing on Hyaluronidase; 1 of which is in the terminal phase. While Lebanon, New hampshire serves as its epicentre, trials for this medication can be found across 140 sites worldwide."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Maryland
What site did they apply to?
Johns Hopkins University
Paria Arfa Fatollahkhani, MD, M.Sc.
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Paria Arfa Fatollahkhani, MD, M.Sc.: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Peripheral Modulation of Muscle Stiffness and Spasticity
2021. "Peripheral Modulation of Muscle Stiffness and Spasticity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03306615.
~8 spots leftby Nov 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top