BOTOX® Drug Use Investigation (Spasmodic Dysphonia)

Study Overview
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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.

Official Title
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Botox Drug Use Investigation (Spasmodic Dysphonia)

Conditions
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Dysphonia

Intervention / Treatment
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* Drug: BOTOX


Participation Criteria
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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. Exclusion Criteria: Not applicable
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects receiving BOTOX<br>Subjects with a diagnosis of spasmodic dysphonia, for which BOTOX is indicated, will be included. | Drug: BOTOX<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse drug reactions | 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. | Up to 1 year | 
| Change from Baseline in voice handicap index (VHI)-10 scores | 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. | Baseline and up to 1 year | 
| Efficacy rate based on global assessment of efficacy | 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. | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spasmodic Dysphonia, VHI-10 scores, BOTOX, Drug use investigation