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Can botox doses be optimized for kids with cerebral palsy?

NCT ID NCT06150729

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study looks at how Botox (OnabotulinumtoxinA) is used in real-world clinical practice to treat muscle stiffness in children aged 2-17 with cerebral palsy. Researchers will track dosing, injection techniques, and pain management methods over 12 months. The goal is to understand current practices and gather information that could help improve treatment approaches.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OnabotulinumtoxinA (Botox) injections
What this could lead to
If successful, this could help refine how Botox is used to ease muscle stiffness in children with cerebral palsy, potentially improving treatment guidelines.
What could go wrong
This is an observational study, so it won't prove effectiveness. Results may vary widely due to real-world practice differences and small sample size.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

107 people

The number who actually took part.

Started

Sep 2023

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cerebral palsy Muscle Spasticity spastic cerebral palsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spasticity

Contacts and locations

Locations

  • Clinica de Rehabilitacion Integral Yupi /Id# 261461

    Puerto Vallarta, Jalisco, 48312, Mexico

  • Cree Dif Nuevo Leon /Id# 261454

    Monterrey, Nuevo LEON, Nuevo León, 64790, Mexico

  • Cri Dif Jalisco /Id# 261459

    Guadalajara, 44270, Mexico

  • Crit Estado de México /Id# 261934

    Tlalnepantla, 54010, Mexico

  • Hospital General ISSSTE Tacuba /ID# 261460

    Mexico City, Mexico City, 11410, Mexico

  • Hospital General ISSSTE Tacuba /ID# 261932

    Mexico City, Mexico City, 11410, Mexico

  • Hospital General Regional 180 IMSS /ID# 261458

    Guadalajara, Jalisco, 45653, Mexico

  • Hospital Militar De Zona De Villahermosa /ID# 261451

    Villahermosa, Tabasco, 86100, Mexico

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