Real World Effectiveness and Safety of Deutetrabenazine in Adult Chinese Participants With Huntington's Disease (HD) Chorea in China
2026年8月3日 更新者：Teva Branded Pharmaceutical Products R&D LLC
Real-World Effectiveness and Safety of Deutetrabenazine in Chinese Patients With Chorea Associated With Huntington's Disease.
The Primary Objective: To evaluate the real-world effectiveness of deutetrabenazine in adult participants with chorea associated with Huntington's disease in China.
The Secondary Objectives: To evaluate the real-world safety of deutetrabenazine in adult participants with chorea associated with Huntington's disease in China.
調査の概要
研究の種類
介入
入学 (実際)
50
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
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Beijing、中国、100053
- Teva Investigational Site 03
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Beijing、中国、100070
- Teva Investigational Site 02
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Chengdu、中国、610041
- Teva Investigational Site 01
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Participants with clinically confirmed diagnosis of chorea associated with Huntington's Disease (HD)
- Participants whose baseline total maximal chorea (TMC) score ≥ 8
- Participants who are deutetrabenazine-naïve before study entry or who did not receive deutetrabenazine within 30 days of study entry, and who are about to be treated with deutetrabenazine for chorea associated with HD
- Participants who have provided written consent for the use of personal and medical information for study purposes
Exclusion Criteria:
- Participants who have an unstable or serious medical or psychiatric illness at baseline
- Participants with any history of suicidality, untreated or inadequately treated depression
- Participants with certain comorbidities, including hepatic impairment, congenital long QT syndrome, and clinically significant cardiac arrhythmias.
- Participants who received reserpine within 20 days of deutetrabenazine treatment initiation
- Participants who received monoamine oxidase inhibitors within 14 days of deutetrabenazine treatment initiation
- Participants who received vesicular monoamine transporter 2 (VMAT2) inhibitors, e.g., tetrabenazine or valbenazine, within 30 days of deutetrabenazine treatment initiation
- Participants unable to provide a written consent for the study.
- Participants who are participating in another study that includes treatment with an investigational drug and/or intervention at the same time as enrolment in the current study
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Deutetrabenazine
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deutetrabenazine tablets
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in TMC Score in Participants Receiving ≥24 mg/Day
時間枠：Baseline, Week 16
|
The TMC score was determined from Item 12 of the motor assessment (Part 1) of the UHDRS and quantifies chorea (range, 0-28, lower score indicated less chorea).
It was the sum of maximal chorea scores for 7 body regions (face, buccal-oral-lingual, trunk, and 4 extremities), each of which was scored on a scale from 0 to 4 (0, absent; 1, slight or intermittent; 2, mild and common or moderate and intermittent; 3, moderate and common; and 4, marked and prolonged).
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Baseline, Week 16
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Any Adverse Events (AEs) By Severity Grade
時間枠：Baseline up to Week 16
|
AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Severity of AEs recorded as one of following Common Terminology Criteria for Adverse Events (CTCAE) criteria: -Grade 1: Mild; asymptomatic or mild symptoms; clinical/diagnostic observations only; intervention not indicated.
-Grade 2: Moderate; local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL) (for example, preparing meals, shopping for groceries or clothes, using telephone).
-Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization; disabling; limiting self-care ADL (bathing, dressing, feeding self, using toilet, taking medications, and not bedridden).
-Grade 4: Life-threatening; urgent intervention indicated.
-Grade 5: Death related to AE.
A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
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Baseline up to Week 16
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Number of Participants With Serious Adverse Events (SAEs)
時間枠：Baseline up to Week 16
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An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
The SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition.
A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
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Baseline up to Week 16
|
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Number of Participants With Treatment-related AEs
時間枠：Baseline up to Week 16
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An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Number of participants with treatment-related AEs is reported in this outcome measure.
A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
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Baseline up to Week 16
|
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Number of Participants With AEs Leading to Dose Reduction, Interruption, Treatment Discontinuation, and Study Withdrawal
時間枠：Baseline up to Week 16
|
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Number of participants with AEs leading to dose reduction, interruption, treatment discontinuation, and study withdrawal is reported in this outcome measure.
A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
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Baseline up to Week 16
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Number of Participants With AEs in Titration Phase
時間枠：Baseline up to Week 16
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An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
AEs lasted from titration phase to maintenance phase were considered an AE that occurred in the titration phase.
A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
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Baseline up to Week 16
|
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Number of Participants With AEs in Maintenance Phase
時間枠：Baseline up to Week 16
|
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
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Baseline up to Week 16
|
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Number of Participants With AEs of Special Interest
時間枠：Baseline up to Week 16
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An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
AEs of special interest included suicidality, depression, somnolence, QTc prolongation, akathisia, and parkinsonism.
A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
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Baseline up to Week 16
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Change From Baseline in TMC Score in All Participants Regardless of Study Drug Dose
時間枠：Baseline, Week 16
|
The TMC score was determined from Item 12 of the motor assessment (Part 1) of the UHDRS and quantifies chorea (range, 0-28, lower score indicated less chorea).
It was the sum of maximal chorea scores for 7 body regions (face, buccal-oral-lingual, trunk, and 4 extremities), each of which was scored on a scale from 0 to 4 (0, absent; 1, slight or intermittent; 2, mild and common or moderate and intermittent; 3, moderate and common; and 4, marked and prolonged).
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Baseline, Week 16
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Teva Medical Expert, MD、Teva Branded Pharmaceutical Products R&D LLC
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年2月2日
一次修了 (実際)
2025年10月24日
研究の完了 (実際)
2025年10月24日
試験登録日
最初に提出
2026年5月15日
QC基準を満たした最初の提出物
2026年5月15日
最初の投稿 (実際)
2026年5月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月27日
QC基準を満たした最後の更新が送信されました
2026年8月3日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- TV50717-NDG-40182
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan.
Requests will be assessed for scientific merit, product approval status, and conflicts of interest.
If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information.
Please email USMedInfo@tevapharm.com to make your request.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
はい
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