BOTOX® Drug Use Investigation (Spasmodic Dysphonia)

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03543150
Study type	Observational
Source	GlaxoSmithKline
Contact	US GSK Clinical Trials Call Center
Phone	877-379-3718
Email	GSKClinicalSupportHD@gsk.com
Status	Recruiting
Phase
Start date	July 20, 2018
Completion date	February 28, 2022

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