Peripheral Modulation of Muscle Stiffness and Spasticity
Status:
Recruiting
Trial end date:
2023-11-16
Target enrollment:
Participant gender:
Summary
This is a single-center, double-blind, randomized, placebo-controlled, cross-over Phase II
trial of human recombinant hyaluronidase injections in individuals with post-stroke upper
limb muscle stiffness. The investigators will recruit 50 subjects, 25 males and 25 females,
who will be randomized to receive either hyaluronidase plus saline (treatment arm, n=25) or
normal saline (control arm, n=25) injections (first injection) in Phase 1 of the study over 5
visits that will test all 3 study aims. Then subjects will cross over to Phase 2 to receive a
second injection, where the treatment arm will receive the placebo and the placebo arm will
receive the treatment. It is expected that approximately 50 participants will be enrolled to
produce 42 evaluable participants. This design will ensure that all subjects receive the drug
treatment, which will facilitate recruitment. The injecting physician (PI), the assessors,
and the patients will be blind to group assignment. Randomization will be initiated by the
IDS pharmacy as per the study statistician. All patients will be assessed at seven visits
over 9 weeks of the study: Visit 1 - screening and baseline assessment of aims 1 and 2 (week
1-2); Visit 2 - pre-injection MRI for aim 3 (week 1-2); Visit 3 - first injection (week 2);
Visit 4 - post-injection MRI (week 3-5); Visit 5 - post-injection follow up for aims 1 and 2
(week 3-5); CROSSOVER TO OPPOSITE TREATMENT ARM Visit 6 - Second injection (week 6); Visit 7
- post-injection follow-up for aims 1 and 2/ final study visit (week 7-9). There will be no
MRI assessment after the second injection as the technique is adequately sensitive to
demonstrate changes with a small sample size. The investigators will follow the patients for
approximately 9 weeks in this study. After obtaining informed consent, subjects will be
screened to ensure that the subjects meet study criteria.
Phase:
Phase 2
Details
Lead Sponsor:
Johns Hopkins University New York University School of Medicine