Study of Intramuscular Injections of OnabotulinumtoxinA to Assess Change in Disease Activity in Pediatric Participants With Spasticity Associated With Cerebral Palsy

Study Identifier
P24-430
CT.gov Identifier
NCT06150729
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Movement Disorders - Other
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    2 - 17 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Unilateral/bilateral, upper/lower limb spasticity associated with cerebral palsy. * Naïve to OnabotulinumtoxinA treatment and who, according to medical and to the standard clinical practice criteria, will receive OnabotulinumtoxinA. * Treated only with stable doses of short-acting muscle relaxants can be included in the study, at the investigator's discretion, for at least 30 days prior to treatment starting, under the concept that at the time the steady state of the drug (stable plasma concentrations) will theoretically have been reached. * Under adjuvant treatment with orthoses and other orthopedic devices can be included in the study. * Participants with physio/physical therapy can be included.
    Exclusion Criteria:
    * Previously treated with botulinum toxin for spasticity related to cerebral palsy. * Diagnosed with Eaton-Lambert syndrome, myasthenia gravis, or other neurological diseases with compromised neuromuscular transmission. * History of hypersensitivity to the study drug or to any of the excipients in the formulation. * Evidence of inflammation or infection in the anatomical region selected by the investigator for the study drug administration. * Participants under treatment with drugs that interfere with neuromuscular transmission which, at the investigator's discretion, contraindicate OnabotulinumtoxinA concomitant administration. * Have had orthopedic surgery in the segment to be infiltrated in the 12 months prior to drug application.

    Protocol Summary

    Spasticity is often observed as muscle tightness and stiffness in the upper and/or lower limbs. Upper limb spasticity can interfere with joint movement and its severity can range from mild to severe. This study will assess how effective OnabotulinumtoxinA is in treating pediatric participants with Spasticity. Change in disease activity will be evaluated.

    OnabotulinumtoxinA is approved drug for treatment of Spasticity. Approximately 106 pediatric participants aged 2-17 years with spasticity associated with cerebral palsy will be enrolled in approximately 10 sites across Mexico.

    Participants will receive OnabotulinumtoxinA as prescribed by their physician in accordance to local label and followed for 12 months.

    There is expected to be no additional burden for participants in this trial. Participants will attend regular visits to a hospital or clinic in their routine practice.

    Study Locations

    Location
    Status
    Location
    Hospital General Regional 180 IMSS /ID# 261458
    Guadalajara, Jalisco, Mexico, 45653
    Status
    Not applicable
    Location
    Clinica de Rehabilitacion Integral Yupi /Id# 261461
    Puerto Vallarta, Jalisco, Mexico, 48312
    Status
    Not applicable
    Location
    Hospital General ISSSTE Tacuba /ID# 261460
    Mexico City, Mexico City, Mexico, 11410
    Status
    Not applicable
    Location
    Hospital General ISSSTE Tacuba /ID# 261932
    Mexico City, Mexico City, Mexico, 11410
    Status
    Not applicable
    Location
    Cree Dif Nuevo Leon /Id# 261454
    Monterrey, Nuevo LEON, Nuevo León, Mexico, 64790
    Status
    Not applicable
    Location
    Hospital Militar De Zona De Villahermosa /ID# 261451
    Villahermosa, Tabasco, Mexico, 86100
    Status
    Not applicable
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