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

Last updated: June 21, 2024
Sponsor: AbbVie
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Limb Spasticity

Dystonia

Cerebral Palsy

Treatment

N/A

Clinical Study ID

NCT06150729
P24-430
  • Ages 2-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Unilateral/bilateral, upper/lower limb spasticity associated with cerebral palsy.

  • Naïve to OnabotulinumtoxinA treatment and who, according to medical and to thestandard clinical practice criteria, will receive OnabotulinumtoxinA.

  • Treated only with stable doses of short-acting muscle relaxants can be included inthe study, at the investigator's discretion, for at least 30 days prior to treatmentstarting, under the concept that at the time the steady state of the drug (stableplasma concentrations) will theoretically have been reached.

  • Under adjuvant treatment with orthoses and other orthopedic devices can be includedin the study.

  • Participants with physio/physical therapy can be included.

Exclusion

Exclusion Criteria:

  • Previously treated with botulinum toxin for spasticity related to cerebral palsy.

  • Diagnosed with Eaton-Lambert syndrome, myasthenia gravis, or other neurologicaldiseases with compromised neuromuscular transmission.

  • History of hypersensitivity to the study drug or to any of the excipients in theformulation.

  • Evidence of inflammation or infection in the anatomical region selected by theinvestigator for the study drug administration.

  • Participants under treatment with drugs that interfere with neuromusculartransmission which, at the investigator's discretion, contraindicateOnabotulinumtoxinA concomitant administration.

  • Have had orthopedic surgery in the segment to be infiltrated in the 12 months priorto drug application.

Study Design

Total Participants: 107
Study Start date:
September 08, 2023
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • Hospital General ISSSTE Tacuba /ID# 261460

    Ciudad de México, Ciudad De Mexico 11410
    Mexico

    Site Not Available

  • Hospital General ISSSTE Tacuba /ID# 261932

    Ciudad de México, Ciudad De Mexico 11410
    Mexico

    Site Not Available

  • Hospital General Regional 180 IMSS /ID# 261458

    Guadalajara, Jalisco 45653
    Mexico

    Site Not Available

  • Hospital Militar De Zona De Villahermosa /ID# 261451

    Villahermosa, Tabasco 86100
    Mexico

    Site Not Available

  • Cri Dif Jalisco /Id# 261459

    Guadalajara, 44270
    Mexico

    Site Not Available

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