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

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

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 Overview

• Status: Recruiting
• Conditions: Spasticity

• Study Type: Observational
• Enrollment (Estimated): 106

Contacts and Locations

• Study Contact: Name: Angel Mario Coll Munoz; Phone Number: +52 5543935017; Email: angel.coll@abbvie.com

Study Locations

• Mexico
  • Guadalajara, Mexico, 44270
    • Recruiting
    • Cri Dif Jalisco /Id# 261459
  • Ciudad De Mexico
    • Ciudad de México, Ciudad De Mexico, Mexico, 11410
      • Recruiting
      • Hospital General ISSSTE Tacuba /ID# 261460
    • Ciudad de México, Ciudad De Mexico, Mexico, 11410
      • Recruiting
      • Hospital General ISSSTE Tacuba /ID# 261932
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 45653
      • Recruiting
      • Hospital General Regional 180 IMSS /ID# 261458
  • Tabasco
    • Villahermosa, Tabasco, Mexico, 86100
      • Recruiting
      • Hospital Militar De Zona De Villahermosa /ID# 261451

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Pediatric Participants (2-17 years) with spasticity associated with cerebral palsy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
OnabotulinumtoxinA; Participants will receive OnabotulinumtoxinA as prescribed by their physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Total Dose	OnabotulinumtoxinA total dose applied at visit will be assessed.	Up to 12 months
Total Dose Per Kilogram	OnabotulinumtoxinA total dose applied at each visit, divided by patient's body weight will be assessed.	Up to 12 months
Dose Per Muscle	OnabotulinumtoxinA dose applied to each muscle, regardless of punctures' number on that muscle will be assessed.	Up to 12 months
Application Sites Number Per Muscle	Number of puncture sites per muscle will be assessed.	Up to 12 months
Re-administration Interval	Re-administration interval is defined as number of days between drug application and previous application.	Up to 12 months
Needle Gauge	Needle gauge is defined as diameter of needle thickness with which study treatment is applied.	Up to 12 months
Needle Length	Needle length is defined as distance from the needle base to the needle bevel tip.	Up to 12 months
Preventive Pain Management Technique	Type of method used to control procedural pain will be assessed.	Up to 12 months
Method to Locate Application Site	Type of method used to identify muscle and treatment application site will be assessed.	Up to 12 months

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Cerebral Palsy; OnabotulinumtoxinA; Spasticity
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity
• Other Study ID Numbers: P24-430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No