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

Spasticity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06150729
• Other study ID #: P24-430
• Status: Recruiting
• Start date: September 8, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: Angel Mario Coll Munoz
• Phone: +52 5543935017
• Email: angel.coll[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: May 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Spasticity

Locations

Country	Name	City	State
Mexico	Hospital General ISSSTE Tacuba /ID# 261460	Ciudad de México	Ciudad De Mexico
Mexico	Hospital General ISSSTE Tacuba /ID# 261932	Ciudad de México	Ciudad De Mexico
Mexico	Cri Dif Jalisco /Id# 261459	Guadalajara
Mexico	Hospital General Regional 180 IMSS /ID# 261458	Guadalajara	Jalisco
Mexico	Hospital Militar De Zona De Villahermosa /ID# 261451	Villahermosa	Tabasco

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Mexico, 

Outcome

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

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