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.
Study Type
OBSERVATIONAL
Enrollment
400
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.
GSK Investigational Site
Tokyo, Japan
RECRUITINGNumber 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 year
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