Collagenase Injection for Spasticity Management (NCT07693569) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Collagenase Injection for Spasticity Management
United States15 participantsStarted 2026-09-01
Plain-language summary
The overall goal is to investigate the effectiveness of a novel intervention - Collagenase injection, for spasticity management in patients with neurological impairments, such as stroke, brain injury, and spinal cord injury.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥ 6 months post stroke, brain injury or spinal cord injury, medically stable;
* MAS ≥ 1
Exclusion Criteria:
* Is hypersensitive to XIAFLEX or collagenase;
* Is currently adjusting tone alternating medications (e.g., baclofen), or
* Received botulinum toxin injection to target areas \<4 months, or phenol injections \< 9 months;
* Received surgical release of tendons;
* Is a pregnant woman;
* Has coagulation disorders, including those who receive concomitant anticoagulants (except for low-dose aspirin).
* has heritable connective tissue disorders, including those within the Ehlers-Danlos syndrome (EDS) spectrum.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in spasticity as assessed by the Modified Ashworth Scale (MAS)
Timeframe: Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections
2
Safety as assessed by the number of adverse events
Timeframe: From baseline to end of study (3 months post-injections)
Trial details
NCT IDNCT07693569
SponsorThe University of Texas Health Science Center, Houston