BOTOX® Drug Use Investigation (Spasmodic Dysphonia)

• Conditions: Dysphonia
• Interventions: Drug: BOTOX

• Registration Number: NCT03543150
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-06-01
• Study Start: 2018-07-20
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-07
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse drug reactions	Up to 1 year	The investigator will collect the information about all adverse drug reactions including diseases and symptoms, occurring after the first administration of Botox, regardless of whether they are related to BOTOX.
Change from Baseline in voice handicap index (VHI)-10 scores	Baseline and up to 1 year	The VHI is a 30-item questionnaire divided into 3 subsections including functional, physical, and emotional which measures the effect of voice problems on quality of life. Subjects will mark each item on this 30-item questionnaire on a scale ranging from 0-4 (0 being never and 4 being always). Points for each subscale are tallied and a total composite score is also given. A total score of 0-11 is considered normal, 12-28 is considered mild minimal handicap, 29-56 is considered moderate handicap, and 57-120 is considered severe handicap.
Efficacy rate based on global assessment of efficacy	Up to 1 year	The efficacy rate is the number of subjects assessed as "effective" based on the course of subjective symptoms and clinical symptoms during the observation period from the date of the first administration of BOTOX injections.

Trial Locations

Locations (1)

GSK Investigational Site; 🇯🇵 Tokyo, Japan