Safety on Switching Between Different Botulinum Toxin-A

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Drug: Botulinum toxin type A

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 118

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli, Turkey
    • Kocaeli University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

No active study treatment will be given as this will be a retrospective study. Information on children with at least two subsequent injection of two different types of toxinA for the treatment of spasticity will be collected and analysed

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurence of treatment related adverse events	Overall and per injection cycle	Up to 30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale	Spasticity Assessment Scale	Up to 30 months
Tardieu Scale	Spasticity Assessment Scale	Up to 30 months
Observational Gait Scale	Gait Assessment Scale	Up to 30 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goal Attainment Scale	Outcome measure for goal selection and goal scaling	Up to 30 months

Collaborators and Investigators

• Sponsor: Nigar Dursun
• Investigators: Study Director: Nigar Dursun, MD, Kocaeli University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 30, 2017
• Primary Completion (ACTUAL): November 30, 2017
• Study Completion (ACTUAL): November 30, 2017

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (ACTUAL): July 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 8, 2018
• Last Update Submitted That Met QC Criteria: January 4, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Botulinum Toxin-A
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: KU GOKAEK 2017/91

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No