Collagenase Injection for Spasticity Management

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07693569
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Spasticity

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 9, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
May 31, 2031
Completion
Sep 30, 2031

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Active XIAFLEX Collagenase injection

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030-

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The University of Texas Health Science Center at Houston· Houston, TX

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