NCT03306615Active, not recruitingPhase 2
Peripheral Modulation of Muscle Stiffness and Spasticity
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- First submitted
- 3 Oct 2017
- Start date
- 11 Oct 2021
- Primary completion date
- 26 Jun 2026
- Lead sponsor
- Johns Hopkins University
- Diseases
- Stroke
- NCT number
- NCT03306615
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 56
- From 11 Oct 2021 to the primary completion date, 26 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- other neurologic condition that may affect motor response (e.g., Parkinson's disease, amyotrophic lateral sclerosis (ALS), MS);
- known hypersensitivity to hyaluronidase;
- Any condition that will preclude the patient from completing the protocol as determined by the PI
Other
- 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;
- claustrophobia;
- standard contraindications for MRI
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins School of Medicine Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.