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Trial record 65 of 720 for:    Botulinum Toxins, Type A

Safety on Switching Between Different Botulinum Toxin-A

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03234413
Recruitment Status : Completed
First Posted : July 31, 2017
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Nigar Dursun, Kocaeli University

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.


Condition or disease Intervention/treatment
Cerebral Palsy 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.

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Study Type : Observational
Actual Enrollment : 118 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Switching Between Different Types of Botulinum Toxin-A in Children With Cerebral Palsy Treated for Spasticity: a Safety Retrospective Evaluation
Actual Study Start Date : July 30, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Botulinum toxin type A
    Botulinum toxin type A
    Other Name: Botox, Dysport


Primary Outcome Measures :
  1. Occurence of treatment related adverse events [ Time Frame: Up to 30 months ]
    Overall and per injection cycle


Secondary Outcome Measures :
  1. Modified Ashworth Scale [ Time Frame: Up to 30 months ]
    Spasticity Assessment Scale

  2. Tardieu Scale [ Time Frame: Up to 30 months ]
    Spasticity Assessment Scale

  3. Observational Gait Scale [ Time Frame: Up to 30 months ]
    Gait Assessment Scale


Other Outcome Measures:
  1. Goal Attainment Scale [ Time Frame: Up to 30 months ]
    Outcome measure for goal selection and goal scaling



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234413


Locations
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Turkey
Kocaeli University
Kocaeli, Turkey
Sponsors and Collaborators
Nigar Dursun
Investigators
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Study Director: Nigar Dursun, MD Kocaeli University

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Responsible Party: Nigar Dursun, Professor, MD, Kocaeli University
ClinicalTrials.gov Identifier: NCT03234413     History of Changes
Other Study ID Numbers: KU GOKAEK 2017/91
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Nigar Dursun, Kocaeli University:
Botulinum Toxin-A

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents