Safety on Switching Between Different Botulinum Toxin-A

Completed

• Conditions: Cerebral Palsy

• Registration Number: NCT03234413
• Lead Sponsor: Nigar Dursun

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-07-19
• Study First Submitted QC: 2017-07-28
• Study Start: 2017-07-30
• Study First Posted: 2017-07-31
• Primary Completion: 2017-11-30
• Study Completion: 2017-11-30
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurence of treatment related adverse events	Up to 30 months	Overall and per injection cycle

Secondary Outcome Measures

Name	Time	Method
Observational Gait Scale	Up to 30 months	Gait Assessment Scale
Modified Ashworth Scale	Up to 30 months	Spasticity Assessment Scale
Tardieu Scale	Up to 30 months	Spasticity Assessment Scale

Trial Locations

Locations (1)

Kocaeli University; 🇹🇷 Kocaeli, Turkey