BOTOX® Drug Use Investigation (Spasmodic Dysphonia)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-20

Study Completion Date

2022-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Dysphonia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects receiving BOTOX

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

BOTOX

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.