Last updated: 01/28/2025 09:50:17
BOTOX® Drug Use Investigation (Spasmodic Dysphonia)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Case-Only
Primary completion date:
2022-28-01
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)
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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