Safety on Switching Between Different Botulinum Toxin-A

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03234413
• Other study ID #: KU GOKAEK 2017/91
• Status: Completed
• Phase: N/A
• First received: July 19, 2017
• Last updated: January 4, 2018
• Start date: July 30, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: January 2018
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Drug:
• Botulinum toxin type A
Botulinum toxin type A

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Nigar Dursun

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Goal Attainment Scale	Outcome measure for goal selection and goal scaling	Up to 30 months
Primary	Occurence of treatment related adverse events	Overall and per injection cycle	Up to 30 months
Secondary	Modified Ashworth Scale	Spasticity Assessment Scale	Up to 30 months
Secondary	Tardieu Scale	Spasticity Assessment Scale	Up to 30 months
Secondary	Observational Gait Scale	Gait Assessment Scale	Up to 30 months