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

Active, not recruiting

• Conditions: Spasticity

• Registration Number: NCT06150729
• Lead Sponsor: AbbVie

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-08
• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2023-11-21
• Study First Posted: 2023-11-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-25
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 107

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (5)

Hospital General ISSSTE Tacuba /ID# 261460; 🇲🇽 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, Mexico

Hospital General ISSSTE Tacuba /ID# 261932; 🇲🇽 Ciudad de México, Ciudad De Mexico, Mexico