Clinical trial NCT06150729: Study of Intramuscular Injections of OnabotulinumtoxinA to Assess Change in Disease Activity in Pediatric Participants With Spasticity Associated With Cerebral Palsy
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Spasticity
Keywords: Spasticity
Cerebral Palsy
OnabotulinumtoxinA
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-11-29
Enrollment: 107
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric Participants (2-17 years) with spasticity associated with cerebral palsy.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Absolute Total Dose
timeFrame: Up to 12 months
measure: Total Dose Per Kilogram
timeFrame: Up to 12 months
measure: Dose Per Muscle
timeFrame: Up to 12 months
measure: Application Sites Number Per Muscle
timeFrame: Up to 12 months
measure: Re-administration Interval
timeFrame: Up to 12 months
measure: Needle Gauge
timeFrame: Up to 12 months
measure: Needle Length
timeFrame: Up to 12 months
measure: Preventive Pain Management Technique
timeFrame: Up to 12 months
measure: Method to Locate Application Site
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ciudad de México
country: Mexico
facility: Hospital General ISSSTE Tacuba /ID# 261460
state: Ciudad De Mexico
city: Ciudad de México
country: Mexico
facility: Hospital General ISSSTE Tacuba /ID# 261932
state: Ciudad De Mexico
city: Guadalajara
country: Mexico
facility: Hospital General Regional 180 IMSS /ID# 261458
state: Jalisco
city: Villahermosa
country: Mexico
facility: Hospital Militar De Zona De Villahermosa /ID# 261451
state: Tabasco
city: Guadalajara
country: Mexico
facility: Cri Dif Jalisco /Id# 261459
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: