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NCT Number: NCT07693569

Collagenase Injection for 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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

  2. Safety as assessed by the number of adverse events

    Time frame: From baseline to end of study (3 months post-injections)

    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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sheng Li, MD, PhD

CONTACT

[email protected]

(713) 797-7125

Shengai Li, MS

CONTACT

[email protected]

713-797-7561

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Collagenase Injection for Contracture and Spasticity Management

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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