Not yet recruiting NCT07693569
Collagenase Injection for Spasticity Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: XIAFLEX Collagenase injection.
- Who it may be relevant to
- Registry conditions: Spasticity. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Collagenase Injection for Contracture and Spasticity Management
Overview
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.
Interventions
- Biological XIAFLEX Collagenase injection
Collagenase is an enzyme that breaks down collagen, which is a key component of connective tissue, such as fascia. XIAFLEX is an FDA-Approved collagenase for treatment of Dupuytren's contracture with a palpable cord in the fingers, and Peyronie's disease in the penile tissue. In this research project, we plan to use collagenase to treat spasticity in patients with neurological impairments, such as stroke, brain injury, and spinal cord injury. FDA guidelines will be followed for dosing and patien
Primary outcome measures
- Change in spasticity as assessed by the Modified Ashworth Scale (MAS) [Time frame: Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections]
- Safety as assessed by the number of adverse events [Time frame: From baseline to end of study (3 months post-injections)]
Secondary outcome measures (2)
- Change in range of motion of target joints as assessed by the Passive Range of Motion (PROM) [Time frame: Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections]
- Change in range of motion of target joints as assessed by the Active Range of Motion (AROM) [Time frame: Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT07693569 · HSC-MS-25-0499 (Experiment 1)