Collagenase Injection for Spasticity Management

Collagenase Injection for Contracture and Spasticity Management

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spasticity
• Intervention / Treatment: Biological: XIAFLEX Collagenase injection

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Sheng Li, MD, PhD; Phone Number: (713) 797-7125; Email: sheng.li@uth.tmc.edu
• Study Contact Backup: Name: Shengai Li, MS; Phone Number: 713-797-7561; Email: shengai.li@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Active XIAFLEX Collagenase injection

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Safety as assessed by the number of adverse events	Adverse events include; 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.; XIAFLEX injection is likely to result in swelling, bruising, bleeding, and/or pain of the injected site and surrounding tissue.	From baseline to end of study (3 months post-injections)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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.	Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Sheng Li, MD, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 31, 2031
• Study Completion (Estimated): September 30, 2031

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity
• Other Study ID Numbers: HSC-MS-25-0499 (Experiment 1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No