BOTOX® Drug Use Investigation (Spasmodic Dysphonia)

GlaxoSmithKline (GSK)

Status: Unknown

Conditions: Dysphonia

Treatments: Drug: BOTOX

Study type: Observational

Funder types: Industry

Identifiers

NCT03543150

208506

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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 design

400 participants in 1 patient group

Subjects receiving BOTOX

Description:

Subjects with a diagnosis of spasmodic dysphonia, for which BOTOX is indicated, will be included.

Treatment:

Drug: BOTOX