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Completed

NCT Number: NCT03234413

Safety on Switching Between Different Botulinum Toxin-A

Clinical guidelines recommend the use of Botulinum Toxin-A (BoNT-A) for localized/segmental spasticity in children with cerebral palsy. At the Kocaeli University (KOU) Department of Physical Medicine and Rehabilitation (PMR) more than 800 patients have been injected with the two approved toxinA types; OnabotulinumtoxinA or AbobotulinumtoxinA.

With this study investigators would like to evaluate retrospectively if switching from one toxin to another is safe as well as to evaluate if the efficacy when switching from one toxin to another was maintained.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kocaeli University

Kocaeli, Turkey (Türkiye)

About this study

A data base was designed to capture all data that were considered relevant to the treatment evaluation. The data were transcribed directly from participants medical records. For the purpose of the study, data from the two subsequent visits where a different type of toxin was given will be collected and evaluated . In order to collect the pre and post status in terms of safety and efficacy, for each participant, data corresponding to the 6 previous and posterior months after the switch of the toxin will also be collected or data corresponding to the previous and posterior visit after the switch of the toxin will also be collected.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children diagnosis of cerebral palsy with respect to Rosenbaum criteria,
  • children having received repeated injections with two different types of toxinA treatment into their lower limb(s)

Exclusion criteria

  • children without repeated Botulinum toxin type A injections
  • children having received repeated injections with same type of toxinA

Treatment and study plan

Botulinum Toxin Type A

Drug

Botulinum toxin type A

Other names: Botox, Dysport

Primary outcomes

  1. Occurence of treatment related adverse events

    Time frame: Up to 30 months

    Overall and per injection cycle

Secondary outcomes

  1. Modified Ashworth Scale

    Time frame: Up to 30 months

    Spasticity Assessment Scale

  2. Tardieu Scale

    Time frame: Up to 30 months

    Spasticity Assessment Scale

  3. Observational Gait Scale

    Time frame: Up to 30 months

    Gait Assessment Scale

Other outcomes

  1. Goal Attainment Scale

    Time frame: Up to 30 months

    Outcome measure for goal selection and goal scaling

Sponsors and collaborators

Lead sponsor

Nigar Dursun

Other

Registry information

Official study title

Switching Between Different Types of Botulinum Toxin-A in Children With Cerebral Palsy Treated for Spasticity: a Safety Retrospective Evaluation

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 31, 2017
Registry last updated
Jan 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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