NCT03543150

BOTOX® Drug Use Investigation (Spasmodic Dysphonia)

Botox Drug Use Investigation (Spasmodic Dysphonia)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Dysphonia

Interventions

Type	Name	Description
DRUG	BOTOX	BOTOX injections will be administered to eligible subjects with diagnosis of spasmodic dysphonia. Dose unit, daily dose frequency, date of administration will be at the investigator discretion.

Timeline

• Start date: 2018-07-20
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2018-06-01
• Last updated: 2021-10-07

Locations

1 site across 1 country: Japan