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

NCT06150729 | Completed

• 1 other identifier: P24-430
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 8

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.

Conditions

Spasticity

Keywords

Spasticity; Cerebral Palsy; OnabotulinumtoxinA

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

OnabotulinumtoxinA

Participants will receive OnabotulinumtoxinA as prescribed by their physician.

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (8)

Hospital General Regional 180 IMSS /ID# 261458

Guadalajara, Jalisco, 45653, Mexico

Location

Clinica de Rehabilitacion Integral Yupi /Id# 261461

Puerto Vallarta, Jalisco, 48312, Mexico

Location

Hospital General ISSSTE Tacuba /ID# 261460

Mexico City, Mexico City, 11410, Mexico

Location

Hospital General ISSSTE Tacuba /ID# 261932

Mexico City, Mexico City, 11410, Mexico

Location

Cree Dif Nuevo Leon /Id# 261454

Monterrey, Nuevo LEON, Nuevo León, 64790, Mexico

Location

Hospital Militar De Zona De Villahermosa /ID# 261451

Villahermosa, Tabasco, 86100, Mexico

Location

Cri Dif Jalisco /Id# 261459

Guadalajara, 44270, Mexico

Location

Crit Estado de México /Id# 261934

Tlalnepantla, 54010, Mexico

Location

Related Links

• Related Info

MeSH Terms

Conditions

Muscle Spasticity; Cerebral Palsy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 29, 2023
• Study Start: September 8, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

ME (8)