Muscle SpasticityPhase 2NCT03306615
Peripheral Modulation of Muscle Stiffness and Spasticity
A Phase 2 study testing Hyaluronidase in people with Muscle Spasticity, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Spasticity
- What is being tested?
- Hyaluronidase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2021to 26 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21231
About this study
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.
Read the detailed description
- To test the effect of hyaluronidase injections on upper limb outcomes. The investigators will test the hypothesis that compared to placebo, human recombinant hyaluronidase injections will increase passive range of motion (ROM) in the most affected joint of the upper limb (primary outcome), isometric muscle strength or force generation capacity using Maximum Voluntary Contraction (MVC) on electromyography (EMG), reduce upper limb motor impairment as measured by the Fugl-Meyer (FM) scale, and improve function as measured by the Wolf Motor Function Test (WMFT).
- To evaluate the effect of hyaluronidase on neural and non-neural components of muscle stiffness. The investigators will test the hypothesis that compared to placebo, intramuscular (IM) hyaluronidase will modulate the passive and potentially also the active component of the stretch reflex, reduce stiffness and improve arm motor control.
- To determine the effect of hyaluronidase on intramuscular glycosaminoglycans (GAG) content. The investigators will test the hypothesis that compared to placebo, IM hyaluronidase will reduce the T1rho relaxation times in the biceps and triceps muscles of the affected arm.
- Conditions
- Muscle Spasticity
- Being tested
- Hyaluronidase, Placebo
- Keywords
- Muscle Stiffness, Muscle Spasticity, Stroke, Cerebral Palsy, Hyperreflexia
- Medical subject headings
- Muscle Spasticity, Stroke, Cerebral Palsy, Reflex, Abnormal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyaluronidaseDrug
Also called Hylenex
HYLENEX recombinant, diluted with 0.9% Sodium Chloride Injection
PlaceboDrug
Also called Normal saline
0.9% Sodium Chloride Injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Hyaluronidase plus saline Receives: Drug: Hyaluronidase |
| Control Arm | Placebo comparator | Normal Saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Most affected upper limb joint passive range of motion (Cohort 1)
passive range of motion in most affected joint across the upper limb
Measured: 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
Measured: 15 weeks
Secondary outcomes (3)
Total upper limb passive and active range of motion
passive and active range of motion in shoulder, elbow and forearm joints
Measured: 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
Measured: 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
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start11 Oct 2021
- Primary completion26 Jun 2026
- Study completion26 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SpasticityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Sheikh Khalifa Stroke Institute
- Responsible party
- Sponsor
- Investigators
- Ning Cao, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306615
- Sponsor's protocol ID
- IRB00273264
- Status last verified
- Jun 2026
- First submitted
- 3 Oct 2017
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Modulation of Muscle Stiffness and Spasticity
- ClinicalTrials.gov ID
- NCT03306615
- Acronym / sponsor ID
- IRB00273264
- Conditions
- Muscle Spasticity
- Keywords
- Muscle Stiffness, Muscle Spasticity, Stroke, Cerebral Palsy, Hyperreflexia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Sheikh Khalifa Stroke Institute
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 26 Jun 2027 (estimated)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- To test the effect of hyaluronidase injections on upper limb outcomes. The investigators will test the hypothesis that compared to placebo, human recombinant hyaluronidase injections will increase passive range of motion (ROM) in the most affected joint of the upper limb (primary outcome), isometric muscle strength or force generation capacity using Maximum Voluntary Contraction (MVC) on electromyography (EMG), reduce upper limb motor impairment as measured by the Fugl-Meyer (FM) scale, and improve function as measured by the Wolf Motor Function Test (WMFT).
- To evaluate the effect of hyaluronidase on neural and non-neural components of muscle stiffness. The investigators will test the hypothesis that compared to placebo, intramuscular (IM) hyaluronidase will modulate the passive and potentially also the active component of the stretch reflex, reduce stiffness and improve arm motor control.
- To determine the effect of hyaluronidase on intramuscular glycosaminoglycans (GAG) content. The investigators will test the hypothesis that compared to placebo, IM hyaluronidase will reduce the T1rho relaxation times in the biceps and triceps muscles of the affected arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: HyaluronidaseHyaluronidase plus saline |
| Control Arm | Placebo comparator | Drug: PlaceboNormal Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyaluronidaseAlso: HylenexHYLENEX recombinant, diluted with 0.9% Sodium Chloride Injection | Drug | Treatment Arm |
| PlaceboAlso: Normal saline0.9% Sodium Chloride Injection | Drug | Control Arm |
Primary outcome
Most affected upper limb joint passive range of motion (Cohort 1)
Time frame: 9 weeks
passive range of motion in most affected joint across the upper limb
Most affected upper limb joint passive range of motion (Cohort 2)
Time frame: 15 weeks
passive range of motion in most affected joint across the upper limb
3 secondary outcomes
Total upper limb passive and active range of motion
Time frame: 15 weeks
Change in upper limb Fugl-Meyer Assessment Score
Time frame: 15 weeks
Change in Wolf-Motor Function Test (WMFT) Score
Time frame: 15 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning Cao, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyaluronidase in people with Muscle Spasticity, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Most affected upper limb joint passive range of motion (Cohort 1) (time frame: 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.