If update date in update history is before 2018/12/15, the information was created in accordance with the old format.

更新履歴 / update history information

項目名 / Item 日本語 / Japanese 英語 / English
最新登録日last update registered date 2021/08/18
最新掲載日last update posted date 2021/08/20
初回登録日first registered date 2020/08/26
初回掲載日first posted date 2020/08/27
結果概要初回登録日first registered date for the result
結果概要初回掲載日first posted date for the result
更新履歴update history 更新日 / updated date 最新照合日 / last reviewed date
2021/08/20 改訂 / revised
2020/08/27 新規作成 / initial created

基本情報 / basic information

項目名 / Item 日本語 / Japanese 英語 / English
JapicCTI-No. JapicCTI-205454
他の登録機関other registries 有 / presence
他の登録機関の名称name of other registries ClinicalTrials.gov
他の登録機関でのID番号secondary ID no. NCT04379050
IPD共有に関する計画plan to share IPD 有 / yes
IPD共有に関する計画の詳細plan description アッヴィは、自社で実施する臨床試験のデータ共有に責任をもって取り組んでいます。このデータには匿名化された被験者レベルと試験レベルのデータ(解
提供期間:データ共有の申請はいつでも可能で、アクセス承認されてから 12 か月間アクセス可能になります。必要に応じて期間延長も検討されます。
究計画、SAP 等の審査、承認を経て、契約を交わした後に提供されます。より詳細な情報と、申請方法についてはこちらでご確認ください。
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and
trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an
ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific
research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data
Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL:

試験名 / title for the study

項目名 / Item 日本語 / Japanese 英語 / English
試験の名称scientific title パーキンソン病患者を対象としたABBV-951 の持続皮下注入による1 日24 時間投与時の安全性及び忍容性を評価するM15-741 試験の非盲検継続試験 [M15-737] An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease [M15-737]
簡易な試験の名称public title 成人パーキンソン病患者を対象としたABBV-951 の持続皮下注入による1 日24 時間投与時の安全性及び忍容性を評価する継続試験 [M15-737] Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease [M15-737]

試験に用いる薬剤等 / investigational material

項目名 / Item 日本語 / Japanese 英語 / English
試験対象薬剤等investigational material 医薬品 / medicine
試験対象薬剤等 / investigational material(s)
一般的名称等generic name etc. ABBV-951 ABBV-951
薬剤:試験薬剤INNINN of investigational material -
試験対象品目:薬剤:薬効分類コードinvestigational material:medicine:therapeutic category code 116 /
用法・用量、使用方法dosage and administration for investigational material 持続皮下注入 Continuous subcutaneous infusion
対照薬剤等 / control material(s)
一般的名称等generic name of control material - -
薬剤:対照薬剤INNINN of control material -
試験対象品目の対照:薬剤:薬効分類コードcontrol material:medicine:therapeutic category code --- /
用法・用量、使用方法dosage and administration for control material - -

試験の概要 / brief summary

項目名 / Item 日本語 / Japanese 英語 / English
試験の目的objective 治療 / treatment
試験のフェーズphase フェーズ3 / phase3
試験の種類study type 介入試験 / interventional study
第1被験者登録・組み入れ日date of first enrolment 2020/09/23
予定試験期間expected duration of study 2020/07/27 ~ 2023/06/22
目標症例数target sample size 15
試験の概要brief summary パーキンソン病(PD)は脳に影響を及ぼす神経学的状態である。PDは時間の経過とともに悪化するが,進行の速さは人によって大きく異なる。パーキンソン病の症状には,振戦,こわばり,及び動作の緩慢さなどがある。本治験の目的は,親試験であるM15-741試験を完了したパーキンソン病患者においてABBV-951の安全性,有効性及び忍容性を継続して検討することである。
被験者にABBV-951を24時間持続皮下注入(CSCI)により、 96週間又は早期中止まで投与する。
Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to continue testing whether ABBV-951 is safe, effective, and tolerable in participants with Parkinson's disease after completion of the parent study M15-741.
ABBV-951 is an investigational (unapproved) drug containing levodopa phosphate/carbidopa phosphate (LDP/CDP) given as infusion under the skin for the treatment of Parkinson's Disease. Participants who have successfully completed M15-741 study will immediately enter this study's treatment period to continue receiving ABBV-951. Adult participants with advanced PD will be enrolled. Approximately 130 adult participants will be enrolled in the study at approximately 65 sites worldwide.
Participants will receive continuous subcutaneous infusion (CSCI) of ABBV-951 for 24 hours daily for 96 weeks or until premature discontinuation.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular clinic visits and have remote assessments completed via phone calls during the course of the study. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
試験のデザインstudy design 割付:該当なし
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
試験実施国・地域countries / regions of recruitment 日本 / Japan
北米 / North America
欧州 / Europe
適格基準inclusion criteria - 親試験であるM15-741 試験を完了した被験者。
- 本治験実施計画書において必要とされる手順を遵守でき,かつおのずから遵守する患者。
- Participants who have Parkinson's Disease and who have successfully completed the parent study M15-741.
- Participants willing and able to comply with procedures required in the protocol.
適格基準:年齢(下限)minimum age 30 歳 / year
適格基準:年齢(上限)maximum age 制限なし / no limitation
適格基準:性別gender 両方 / both
除外基準exclusion criteria - 何らかの理由によりABBV-951の投与継続候補として不適切と治験責任(分担)医師が判断した被験者。 - Participants, if judged by the investigator to be unsuitable candidates to continue to receive ABBV-951 for any reason.
疾患名health condition or problem studied パーキンソン病 Parkinson's Disease
評価項目・方法:主要な評価項目 / primary outcome
評価項目・方法:主要な評価項目primary outcome 安全性 / safety
治験薬 / 治験機器との因果関係の有無にかかわらず,治験薬を投与若しくは治験機器を使用した被験者に生じたあらゆる好ましくない医療上のできごとを有害事象とする。治験責任(分担)医師は,有害事象と治験薬又は治験機器の使用との因果関係が関連あり又は関連なしかを評価する。重篤な有害事象(SAE)は,死亡に至るもの,生命を脅かすもの,入院または入院の延長を必要とするもの,先天性異常,永続的または顕著な障害/機能不全に至るもの,又は医学的判断から被験者を臨床上好ましくない状況に至らしめる事象,あるいは上記の転帰に至らないように内科的または外科的処置を必要とする医学的に重要な事象とする。注目すべき有害事象(AESI)- 多発ニューロパチー,体重減少,幻覚/精神病,及び傾眠は試験期間中観察する。[期間:最大96週間]
3.注入部位評価尺度でD 以上に相当するレターグレードの注入部位反応が認められた被験者の割合
1.Percentage of Participants With Adverse Events (AE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of the study drug or device as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening,
requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Adverse Events of Special Interest (AESI) - polyneuropathy, weight loss, hallucinations/psychosis, and somnolence will be monitored throughout the study. [Time Frame: Up To Week 96]
2.Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale
The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an eight-point numeric scale used to assess irritation at the infusion site area (0 being "no evidence of irritation" and 7 being "strong reaction spreading beyond the test site"). [Time Frame: Up To Week 96]
3.Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale
The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an A to G letter grade scale, used to assess irritation at the infusion site area (A being "no finding" to G being "Small petechial erosions and/or scabs"). [Time Frame: Up To Week 96]
4.Change in Clinical Laboratory Test Data
Number of participants with clinically significant change from baseline in laboratory parameters (hematology, biochemistry, coagulation, and urinalysis) will be reported throughout the study. [Time Frame: Up To Week 96]
5.Change in Vital Signs Measurements
Number of participants with clinically significant change from baseline in vital signs will be reported throughout the study. [Time Frame: Up To Week 96]
6.Change From Baseline in Electrocardiograms (ECGs)
Change from baseline in 12-lead ECGs on heart rate, RR interval, PR interval, QRS duration, and QT interval will be monitored throughout the study. [Time Frame: Up To Week 96]
評価項目・方法:副次的な評価項目 / secondary outcome
評価項目・方法:副次的な評価項目secondary outcome 有効性 / efficacy
PD症状は国際パーキンソン・運動障害学会の統一パーキンソン病評価尺度(MDS-UPDRS)のパートI-IVで評価する。MDS-UPDRSは,治験責任(分担)医師がPDの経時的経過を観察する評価ツールであり,0から236の範囲であり,236 が最も重症度の高い障害を示し,0は障害がないことを示す。[期間:最大96週間]
生活の質はPD質問票-39項目(PDQ-39)により評価する。PDQ-39は,一般的な健康状態に関する質問を含まないPD患者に関連する,健康状態の側面を評価するためにデザインされた疾患別評価尺度である。各項目は5 段階の評価尺度で評価される。[期間:最大96週間]
11.EuroQol 5 項目質問票(EQ-5D-5L)により評価した健康に関連した生活の質のベースラインからの変化
健康に関連した生活の質はEuroQol 5項目質問票(EQ-5D-5L)により評価する。EQ-5D-5Lは,EQ-5D記述システムとEQ視覚的アナログ尺度(EQVAS)の2部から構成される。[期間:最大96週間]
7.Average Normalized Daily "Off" Time
Average normalized daily "Off" Time (Hours) is assessed based on Parkinson's Disease (PD) Diary. [Time Frame: Up To Week 96]
8.Average Normalized Daily "On" Time
Average normalized daily "On" time is assessed based on Parkinson's Disease (PD) Diary. [Time Frame: Up To Week 96]
9.Parkinson's Disease (PD) Symptoms Measurement
PD symptoms will be assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-IV. The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability. [Time Frame: Up To Week 96]
10.Change From Baseline in Quality Of Life Measurement as Assessed by PD Questionnaire-39 (PDQ-39)
Quality of life is assessed by the PD Questionnaire-39 items (PDQ-39). PDQ-39 is a disease-specific instrument designed to measure aspects of health that are relevant to participants with PD, and which may not be included in general health status questionnaires. Each item is scored on a 5-point scale. [Time Frame: Up To Week 96]
11.Change From Baseline in Health-related Quality Of Life Measurement as Assessed by EuroQol 5-dimensions Questionnaire (EQ-5D-5L)
Health-related quality of life is assessed by the EuroQol 5-dimensions questionnaire (EQ-5D-5L). EQ-5D-5L is a standardized instrument that consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue-scale (EQVAS). [Time Frame: Up To Week 96]
12.Cognitive Impairment Measurement
Cognitive impairment is assessed by the Mini-Mental State Examination (MMSE). MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, with higher scores indicating better function. [Time Frame: Up To Week 96]
試験実施施設examination facility
試験の現状study status 実施中 / progressing
被験者募集状況recruitment status 参加募集中 / recruiting
試験終了日または中止日completion date or terminated date

IRB等に関する事項 / information about IRB(s)

項目名 / Item 日本語 / Japanese 英語 / English
名称name of IRB 旭川医療センター 治験審査委員会 Asahikawa Medical Center IRB
住所address of IRB 北海道旭川市花咲町7-4048 7-4048, Hanasakicho,Asahikawa-shi,Hokkaido
電話番号phone number of IRB
Eメールアドレスe-mail address of IRB
審査の状況status of IRB review 承認 / approved
承認日date of approval by IRB 2020/07/21

試験実施組織 / organizations

資金提供組織 / monetary sponsor

項目名 / Item 日本語 / Japanese 英語 / English
組織名称 / name of monetary sponsor
組織名称name of funding organization AbbVie Inc. AbbVie Inc.
研究費の名称name of research funding ABBV-951 M15-741 ABBV-951 M15-741

問合せ先 / contact information

項目名 / Item 日本語 / Japanese 英語 / English
一般的な問合せ先 / public queries
会社名・機関名contact name for public queries アッヴィ合同会社 AbbVie G.K
問合せ部署名department name for contact くすり相談室 Contract for Patients and HCP
連絡先電話番号phone number 0120-587-874 0120-587-874
連絡先Eメールアドレスe-mail address
科学的な問合せ先 / scientific queries
会社名・機関名contact name for scientific queries アッヴィ合同会社 AbbVie G.K
問合せ部署名department name for contact サイトマネジメント&モニタリング部 Site Management & Monitoring
連絡先住所address 東京都港区芝浦3-1-21 3-1-21 Shibaura, Minato-ku, Tokyo
連絡先電話番号phone number
連絡先Eメールアドレスe-mail address

その他 / other

項目名 / Item 日本語 / Japanese 英語 / English
関連の試験番号とその名称related study ID number and its name
関連情報(既存薬の添付文書、審査報告書、新薬承認情報集等) / related information(e.c. package insert for existing medicine)
上記情報の簡易的な説明brief description

試験結果の概要 / result summary

項目名 / Item 日本語 / Japanese 英語 / English
出版物の掲載posting of journal publication
初回の出版物の掲載日date of the first journal publication of results
結果および出版物に関するURLURL hyperlink(s) related to results and publications
試験の対象者に関する背景情報baseline characteristics
実際の症例数actual enrolled number
試験の対象者のフローparticipant flow
有害事象に関するまとめadverse events
主要評価項目の解析結果primary outcome measures
副次的評価項目の解析結果secondary outcome measures
簡潔な要約brief summary
試験のプロトコールファイル:URLURL link to protocol file(s)
試験のプロトコールファイル:版、日付version and date of protocol file(s) 版: