Safety on Switching Between Different Botulinum Toxin-A

NCT03234413 | Completed FDA Drug

• 1 other identifier: KU GOKAEK 2017/91
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Botulinum Toxin-A

Outcome Measures

Primary Outcomes (1)

• Occurence of treatment related adverse events

  Overall and per injection cycle

  Up to 30 months

Secondary Outcomes (3)

• Modified Ashworth Scale

  Up to 30 months

• Tardieu Scale

  Up to 30 months

• Observational Gait Scale

  Up to 30 months

Other Outcomes (1)

• Goal Attainment Scale

  Up to 30 months

Interventions

Botulinum toxin type A DRUG

Botulinum toxin type A

Also known as: Botox, Dysport

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Nigar Dursun: lead

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Nigar Dursun, MD

  Kocaeli University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 31, 2017
• Study Start: July 30, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: January 8, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)