Last updated: 01/28/2025 09:50:17

BOTOX® Drug Use Investigation (Spasmodic Dysphonia)

GSK study ID
208506
See study documents
Clinicaltrials.gov ID
NCT03543150
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Botox Drug Use Investigation (Spasmodic Dysphonia)
Trial description: This study is a drug use investigation program of BOTOX. The objective of this investigation is to collect and assess information on the safety and efficacy of BOTOX injections in subjects with a diagnosis of spasmodic dysphonia in daily clinical practice. All subjects treated with BOTOX for spasmodic dysphonia after obtaining approval for the indication of BOTOX for spasmodic dysphonia will be included in this study. Approximately 400 subjects will be included in the study. The observation period per subject will be up to 12 months from the date of the first administration of BOTOX. The total study duration will be will be approximately 3 years from the date of approval for the indication of BOTOX for spasmodic dysphonia. BOTOX is a registered trademark of Allergan, Inc.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of subjects with adverse drug reactions

Timeframe: Up to 1 year

Change from Baseline in voice handicap index (VHI)-10 scores

Timeframe: Baseline and up to 1 year

Efficacy rate based on global assessment of efficacy

Timeframe: Up to 1 year

Secondary outcomes:
Not applicable
Interventions:
  • Drug: BOTOX
    • Enrollment:
    1582
    Primary completion date:
    2022-28-01
    Observational study model:
    Case-Only
    Time perspective:
    Prospective
    Clinical publications:
    Annette Borchers, Tomas Pieler. Programming pluripotent precursor cells derived from Xenopus embryos to generate specific tissues and organs.. Genes. 2010-11-18;1(3): 413-26. DOI: 10.3390/genes1030413 PMID: 24710095
    Medical condition
    Dysphonia
    Product
    OnabotulinumtoxinA
    Collaborators
    Not applicable
    Study date(s)
    July 2018 to January 2022
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • All subjects treated with Botox for spasmodic dysphonia after obtaining approval for the indication of BOTOX for spasmodic dysphonia are included in this study.
    • Not applicable
    Inclusion and exclusion criteria
    Inclusion criteria:
    • All subjects treated with Botox for spasmodic dysphonia after obtaining approval for the indication of BOTOX for spasmodic dysphonia are included in this study.
    Exclusion criteria:
    • Not applicable

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Tokyo, Japan, 107-0052
    Status
    Study Complete
    Contact us

    Study documents

    Study report synopsis
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2022-28-01
    Actual study completion date
    2022-28-01

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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    Access to clinical trial data by researchers
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