Collagenase Injection for Spasticity Management

NCT07693569 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: HSC-MS-25-0499 (Experiment 1)
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spasticity

Outcome Measures

Primary Outcomes (2)

• 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 1. 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. 2. 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 Outcomes (2)

• Change in range of motion of target joints as assessed by the Passive Range of Motion (PROM)

  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)

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

Study Arms (1)

Active XIAFLEX Collagenase injection

EXPERIMENTAL

Biological: XIAFLEX Collagenase injection

Interventions

XIAFLEX Collagenase injection BIOLOGICAL

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.

Active XIAFLEX Collagenase injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 6 months post stroke, brain injury or spinal cord injury, medically stable;
• MAS ≥ 1

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sheng Li, MD, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng Li, MD, PhD

CONTACT

(713) 797-7125; sheng.li@uth.tmc.edu

Shengai Li, MS

CONTACT

713-797-7561; shengai.li@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 31, 2031
• Study Completion (Estimated): September 30, 2031
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)