Safety on Switching Between Different Botulinum Toxin-A

Nigar Dursun

Status: Completed

Conditions: Cerebral Palsy

Treatments: Drug: Botulinum toxin type A

Study type: Observational

Funder types: Other

Identifiers

NCT03234413

KU GOKAEK 2017/91

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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