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NCT Number: NCT06150729

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

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.

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Key information

Conditions

Spasticity Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy 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

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Regional 180 IMSS /ID# 261458, Guadalajara, Jalisco, Mexico

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Absolute Total Dose

    Time frame: Up to 12 months

    OnabotulinumtoxinA total dose applied at visit will be assessed.

  2. Total Dose Per Kilogram

    Time frame: Up to 12 months

    OnabotulinumtoxinA total dose applied at each visit, divided by patient's body weight will be assessed.

  3. Dose Per Muscle

    Time frame: Up to 12 months

    OnabotulinumtoxinA dose applied to each muscle, regardless of punctures' number on that muscle will be assessed.

  4. Application Sites Number Per Muscle

    Time frame: Up to 12 months

    Number of puncture sites per muscle will be assessed.

  5. Re-administration Interval

    Time frame: Up to 12 months

    Re-administration interval is defined as number of days between drug application and previous application.

  6. Needle Gauge

    Time frame: Up to 12 months

    Needle gauge is defined as diameter of needle thickness with which study treatment is applied.

  7. Needle Length

    Time frame: Up to 12 months

    Needle length is defined as distance from the needle base to the needle bevel tip.

  8. Preventive Pain Management Technique

    Time frame: Up to 12 months

    Type of method used to control procedural pain will be assessed.

  9. Method to Locate Application Site

    Time frame: Up to 12 months

    Type of method used to identify muscle and treatment application site will be assessed.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Botulinum A Toxin (OnabotulinumtoxinA) Use in Mexican Pediatric Population With Spasticity Associated With Cerebral Palsy: Phase IV, Observational, Non-Interventional, Prospective, Multicenter Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2023
Registry last updated
Jul 2, 2025

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

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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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