A Prospective, Observational, Single-Arm, Multicenter Real-World Study Evaluating the Treatment Pattern, Safety and Effectiveness of Xanomeline and Trospium Chloride Capsules (KarXT) in the Treatment of Chinese Adult Participants With Schizophrenia
2026年8月30日 更新者：Zai Lab (Shanghai) Co., Ltd.
This study is a prospective, observational, single-arm, open-label, multicenter, real-world study conducted in Chinese adult participants with schizophrenia who meet the International Classification of Diseases (ICD)-10 diagnostic criteria.
The total study duration is up to 17 weeks, including a screening/baseline data collection period followed by an observational part during which KarXT treatmentpattern, schizophrenia treatment decisions and compliance will be observed in the real-world setting.
調査の概要
研究の種類
観察的
入学 (推定)
250
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。
研究連絡先
- 名前：Hua Shi WANG
- 電話番号：+8618601287374
- メール：shihua.wang@zailaboratory.com
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
サンプリング方法
非確率サンプル
調査対象母集団
In Chinese adult participants with schizophrenia who meet the International Classification of Diseases (ICD)-10 diagnostic criteria
説明
Inclusion Criteria:
- Adult participants (age: ≥18 and ≤65 years) who meet the ICD-10 diagnostic criteria for schizophrenia.
- The participant is capable of providing written informed consent in the study, agrees to receive KarXT monotherapy, is willing to follow the protocol-specified follow-up schedule, and signs the informed consent form, or, where applicable, both the participant and the participant's legal guardian sign the informed consent form.
Exclusion Criteria:
- Participants who have contraindications listed in the prescribing information: urinary retention, moderate or severe hepatic impairment, gastric retention, history of hypersensitivity to this product or trospium chloride, or untreated narrow-angle glaucoma.
- Participants who have conditions not recommended in the prescribing information, such as moderate or severe renal impairment, mild hepatic impairment, or active biliary disease (e.g., symptomatic gallstones).
- Participants diagnosed with treatment-resistant schizophrenia (TRS), defined as having previously received at least two courses of treatment with different antipsychotic medications, with each course administered at an adequate dose, as determined by the investigator based on clinical judgment, for at least 4 weeks, but without response.
- Participants with severe suicidal ideations. Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and C-SSRS as confirmed by the following: Answers "Yes" on items 4 or 5 (C -SSRS ideation) with the most recent episode occurring within the 2 months before screening, or answers "Yes" to any of the 5 items (C-SSRS behavior) with an episode occurring within the 12 months before screening. Non-suicidal self-injurious behavior is not exclusionary.
- Participants who are pregnant, planning to become pregnant, or breastfeeding.
- Participants who have any medical conditions that in the investigator's opinion should exclude them from starting KarXT or participate in this 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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
KarXT Treatment Cohort
The participant is capable of providing written informed consent in this study, agrees to receive KarXT monotherapy
|
Participants will receive KarXT for a treatment/observation period of 17 weeks. The recommended dosage and administration of KarXT should refer to the prescribing information: The recommended starting dosage is one 50 mg/20 mg capsule orally twice daily for at least two days, then increase to one 100 mg/20 mg capsule orally twice daily for at least five days, the dosage may be increased to one 125 mg/30 mg capsule orally twice daily based on participant tolerability and response. All participants who are increased to 125 mg/30 mg, depending on clinician's decision, will have the option to return to 100 mg/20 mg for the remainder of the treatment/observation period. Maintenance doses may be set at 125 mg/30 mg or 100 mg/20 mg twice daily. |
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 |
|---|---|---|
|
KarXTtreatment pattern according to clinicians'decision
時間枠：through Week 17
|
Treatment duration (days)for each doseof KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 17
|
through Week 17
|
|
KarXTtreatment pattern according to clinicians'decision
時間枠：Week 17
|
Proportion(%)of participants on each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) at Week 17
|
Week 17
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
KarXT Safety Profile
時間枠：through Week 17
|
Proportion (%)of KarXT-related adverse events (TRAEs) through Week 17
|
through Week 17
|
|
KarXT Treatment PatternAccording to Clinicians'Decision
時間枠：through Week 5
|
Treatment duration (days) for each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 5
|
through Week 5
|
|
KarXT Safety Profile
時間枠：through Week 17
|
Proportion (%)of serious adverse events (SAEs) through Week 17
|
through Week 17
|
|
KarXT Treatment Effectiveness
時間枠：Week 17
|
Change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 17
|
Week 17
|
|
KarXT Treatment Effectiveness
時間枠：Week 17
|
Change from baseline in the Clinical Global Impression-Severity (CGI-S) score at Week 17
|
Week 17
|
|
Schizophrenia Treatment Decisions and Compliance in the Real-world Setting
時間枠：through Week 17
|
Proportion (%) of participants discontinuing KarXT treatment along with the documented reasons for the decision from baseline through Week 17
|
through Week 17
|
|
KarXT Treatment PatternAccording to Clinicians'Decision
時間枠：through Week 5
|
Proportion (%) of participants on each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 5
|
through Week 5
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in social functional recovery metrics captured via continuous wearable wristband device
時間枠：Baseline and Week 17
|
Change from baseline in social functional recovery metrics captured via continuous wearable wristband device (sleep onset time, wake time, total sleep duration, heart rate, heart rate variability, total daily step count, sedentary duration, and activity interruptions)
|
Baseline and Week 17
|
|
Change from baseline in the proportion of patient-reported outcome in the surveys in binary states across four Ecological Momentary Assessment (EMA) dimensions
時間枠：Baseline and Week 17
|
Observed Ecological Momentary Assessment (EMA) patient-reported outcomes (PRO) in participants with schizophrenia: Change from baseline in the proportion of patient-reported outcome in the surveys in binary states across four Ecological Momentary Assessment (EMA) dimensions: location (at home vs. outdoors), sociality context (alone vs. with others), activity type (productive vs. non-productive), and affect profile (positive vs. negative) at Week 17
|
Baseline and Week 17
|
|
Change From Baseline in the Zarit Caregiver Burden Interview (ZBI) Score
時間枠：Baseline and Week 17
|
Change from baseline in caregiver burden, assessed by the Zarit Caregiver Burden Interview (ZBI)
|
Baseline and Week 17
|
|
Change From Baseline in the PANSS Marder Negative Factor Score
時間枠：Baseline and Week 17
|
Change from baseline in the PANSS Marder negative factor score
|
Baseline and Week 17
|
|
Change From Baseline in the Personal and Social Performance Scale (PSP) Score
時間枠：Baseline and Week 17
|
Change from baseline in the Personal and Social Performance Scale (PSP) score
|
Baseline and Week 17
|
|
Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) Score
時間枠：Baseline and Week 17
|
Change from baseline in participant treatment satisfaction measured by the Medication Satisfaction Questionnaire (MSQ)
|
Baseline and Week 17
|
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。
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 (推定)
2026年9月20日
一次修了 (推定)
2027年8月31日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年8月30日
QC基準を満たした最初の提出物
2026年8月30日
最初の投稿 (実際)
2026年9月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月3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30日
最終確認日
2026年8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
- ZL-2701-007
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?
いいえ
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
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