ボトックス®薬物使用調査（痙攣性発声障害）
基本情報
- NCT ID
- NCT03543150
- ステータス
- 不明
- 試験のフェーズ
- -
- 試験タイプ
- 観察
- 目標被験者数
- 400
- 治験依頼者名
- GlaxoSmithKline
概要
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.