[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07693569":3,"trial-entities:NCT07693569":96,"trial-summary:NCT07693569":99},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":44,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":68,"locations":71,"central_contacts":81,"overall_officials":91,"references":94,"see_also_links":95},"NCT07693569","HSC-MS-25-0499 (Experiment 1)","Collagenase Injection for Spasticity Management","Collagenase Injection for Contracture and Spasticity Management","NOT_YET_RECRUITING","2031-09-30","2026-07","2026-07-09","2026-09-01","The University of Texas Health Science Center, Houston","OTHER",true,"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.",null,[19],"Spasticity",[],"INTERVENTIONAL","TREATMENT",[24],"EARLY_PHASE1",{"count":26,"type":27},15,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"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 patient selection to minimize or reduce the risks.",[34],"Active XIAFLEX Collagenase injection",[36,40],{"measure":37,"description":38,"timeFrame":39},"Change in spasticity as assessed by the Modified Ashworth Scale (MAS)","The Modified Ashworth Scale (MAS) evaluates the increase in muscle tone associated with upper motor neuron lesions. MAS scores will be recorded for the target muscle group(s) at each assessment time point.Scores range from 0 to 4, with an additional grade of 1+ between 1 and 2. Scores are defined as: 0 = no increase in muscle tone; 1 = slight increase in muscle tone with a catch and release or minimal resistance at the end of the range of motion; 1+ = slight increase in muscle tone with a catch followed by minimal resistance through less than half of the range of motion; 2 = more marked increase in muscle tone through most of the range of motion, but the affected part is easily moved; 3 = considerable increase in muscle tone, passive movement difficult; 4 = affected part rigid in flexion or extension.Lower MAS scores indicate reduced spasticity and improved muscle tone, whereas higher scores indicate greater spasticity.","Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections",{"measure":41,"description":42,"timeFrame":43},"Safety as assessed by the number of adverse events","Adverse events include\n\n1. Serious complications of XIAFLEX injection include tendon rupture, serious ligament damage, or skin laceration that may result in the inability to fully bend the joint and may require surgery to correct the complication.\n2. XIAFLEX injection is likely to result in swelling, bruising, bleeding, and\u002For pain of the injected site and surrounding tissue.","From baseline to end of study (3 months post-injections)",[45,48],{"measure":46,"description":47,"timeFrame":39},"Change in range of motion of target joints as assessed by the Passive Range of Motion (PROM)","Range of motion (ROM) refers to the degree of movement available at a joint, measured in degrees using a goniometer. For PROM, the examiner will move the joint to its maximal pain-free range. Measurements will be recorded in degrees, and higher values indicate greater joint mobility.",{"measure":49,"description":50,"timeFrame":39},"Change in range of motion of target joints as assessed by the Active Range of Motion (AROM)","Range of motion (ROM) refers to the degree of movement available at a joint, measured in degrees using a goniometer. For AROM, participants will be instructed to move the joint as far as possible without assistance. Measurements will be recorded in degrees, and higher values indicate greater joint mobility.","ALL","18 Years","75 Years",false,{"inclusion":56,"exclusion":59,"raw_text":67},[57,58],"≥ 6 months post stroke, brain injury or spinal cord injury, medically stable;","MAS ≥ 1",[60,61,62,63,64,65,66],"Is hypersensitive to XIAFLEX or collagenase;","Is currently adjusting tone alternating medications (e.g., baclofen), or","Received botulinum toxin injection to target areas \\\u003C4 months, or phenol injections \\\u003C 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.","Inclusion Criteria:\n\n* ≥ 6 months post stroke, brain injury or spinal cord injury, medically stable;\n* MAS ≥ 1\n\nExclusion Criteria:\n\n* Is hypersensitive to XIAFLEX or collagenase;\n* Is currently adjusting tone alternating medications (e.g., baclofen), or\n* Received botulinum toxin injection to target areas \\\u003C4 months, or phenol injections \\\u003C 9 months;\n* Received surgical release of tendons;\n* Is a pregnant woman;\n* Has coagulation disorders, including those who receive concomitant anticoagulants (except for low-dose aspirin).\n* has heritable connective tissue disorders, including those within the Ehlers-Danlos syndrome (EDS) spectrum.",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"The University of Texas Health Science Center at Houston","Houston","Texas","77030","United States",{"lat":79,"lon":80},29.76328,-95.36327,[82,87],{"name":83,"role":84,"phone":85,"email":86},"Sheng Li, MD, PhD","CONTACT","(713) 797-7125","sheng.li@uth.tmc.edu",{"name":88,"role":84,"phone":89,"email":90},"Shengai Li, MS","713-797-7561","shengai.li@uth.tmc.edu",[92],{"name":83,"affiliation":13,"role":93},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":97,"biomarkers":98},[19],[],{"nct_id":4,"found":15,"summary":100,"prompt_version":109},{"design":101,"status":102,"heading":6,"summary":103,"follow_up":104,"word_count":105,"commitments":106,"compensation":107,"drugs_mentioned":108},"This is an interventional study with a planned enrollment of 15 participants. The phase of the study is not specified.","completed","This study is investigating if XIAFLEX Collagenase injections can help manage spasticity (muscle stiffness) in people who have had a stroke, brain injury, or spinal cord injury. Collagenase is an enzyme that breaks down collagen, a part of connective tissue. The study will measure changes in your spasticity using a tool called the Modified Ashworth Scale (MAS) and track any side effects. You may be able to join if you are 18 to 75 years old, are at least 6 months past your injury, and have a certain level of spasticity (MAS score of 1 or higher). You cannot join if you are allergic to XIAFLEX, are changing certain medications, or have recently had other spasticity treatments or surgery. The current recruitment status is unclear, and the study plans to enroll 15 participants.","Participants will be followed for safety and spasticity changes from baseline to 3 months post-injections.",133,"You would receive XIAFLEX Collagenase injections and have follow-up visits at 2 days, 2 weeks, 1 month, and 3 months after the injections.","Not stated in the trial record.",[31],"v2"]