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GBA-PDにおけるBIA 28-6156の有効性、安全性、忍容性、薬力学、および薬物動態 (ACTIVATE)

2026年11月5日 更新者：Bial R&D Investments, S.A.

グルコセレブロシダーゼ (GBA1) 遺伝子に病的バリアントを持つパーキンソン病患者における BIA 28-6156 の有効性、安全性、忍容性、薬力学、および薬物動態を評価するための第 2 相、無作為化、二重盲検、プラセボ対照試験

The purpose of this randomized, double-blind, placebo-controlled study is to assess the efficacy of BIA 28-6156 over placebo in delaying clinical meaningful motor progression over 78 weeks in subjects with Parkinson's disease who have a pathogenic variant in the glucocerebrosidase 1 (GBA1) gene (GBA-PD).

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This is a 2-part (Part A [Genetic Screening] and Part B [Double-Blind Treatment]), Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of 2 fixed dose levels of BIA 28-6156 (10 and 60 mg/day) in approximately 237 subjects with genetically confirmed GBA-PD.

Part A (Genetic Screening) will identify individuals with a PD risk-associated variant in the GBA1 gene for potential enrolment into Part B (Double-Blind Treatment) of the study. Part B will consist of a screening period to ensure that all protocol inclusion/exclusion criteria for Part B of the study are met (up to 5 weeks). After screening period, eligible subjects will be randomized into 1 of 3 treatment arms (BIA 28-6156 10 mg/day, BIA 28-6156 60 mg/day, or placebo) in a 1:1:1 ratio, and enter a double-blind treatment period up to 78 weeks, followed by a 30-day (4 weeks) of safety follow-up period.

Subjects must be receiving a stable dose of PD medication for at least 30 days before screening (for Part B [Double-Blind Treatment]) and will continue to receive their usual PD medications throughout the study.

研究の種類

介入

入学 (実際)

273

段階

  • フェーズ2

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

  • アメリカ
    • Arizona
      • Phoenix、Arizona、アメリカ、85013
        • Barrow Neurological Institute
    • California
      • La Jolla、California、アメリカ、92037
        • University of California San Diego
      • Los Angeles、California、アメリカ、90048
        • Cedars-Sinai
    • Colorado
      • Aurora、Colorado、アメリカ、80045
        • University of Colorado
    • Florida
      • Boca Raton、Florida、アメリカ、33486
        • Parkinson's Center and Movement Disorders of Boca Raton
      • Miami、Florida、アメリカ、33136
        • University of Miami, Dept. of Neurology
      • Ocala、Florida、アメリカ、34470
        • Renstar Medical Research
    • Georgia
      • Atlanta、Georgia、アメリカ、30310
        • Morehouse School of Medicine
    • Illinois
      • Chicago、Illinois、アメリカ、60611
        • Northwestern University
      • Chicago、Illinois、アメリカ、60612
        • Rush University Medical Center
    • Iowa
      • Iowa City、Iowa、アメリカ、52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City、Kansas、アメリカ、66103
        • University of Kansas Medical Center
    • Kentucky
      • Lexington、Kentucky、アメリカ、40536
        • University of Kentucky
    • Maryland
      • Baltimore、Maryland、アメリカ、21201
        • University of Maryland Medical Center
      • Baltimore、Maryland、アメリカ、21287
        • The Johns Hopkins University School of Medicine
      • Baltimore、Maryland、アメリカ、21287
        • Baylor University Medical Center
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02114
        • Massachusetts General Hospital
      • Boston、Massachusetts、アメリカ、02115
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Farmington Hills、Michigan、アメリカ、48334
        • Quest Research Institute, LLC
    • Minnesota
      • Rochester、Minnesota、アメリカ、55905
        • Mayo Clinic
      • Saint Paul、Minnesota、アメリカ、55130
        • Struthers Parkinson's Center- East
      • Saint Paul、Minnesota、アメリカ、55427
        • Park Nicollet Struther's Parkinson's Center (Struthers Parkinsons Center at HealthPartners)
    • New Jersey
      • New Brunswick、New Jersey、アメリカ、08901
        • Robert Wood Johnson Medical School
    • New York
      • New York、New York、アメリカ、10032
        • Columbia University Medical Center
      • New York、New York、アメリカ、10075
        • Northwell Health
      • New York、New York、アメリカ、10003
        • Icahn School of Medicine at Mount Sinai Beth Israel
      • New York、New York、アメリカ、10021
        • Weil Cornell Medical Center
      • New York、New York、アメリカ、10075-1851
        • Northwell Health Physician Partners
      • Rochester、New York、アメリカ、14642
        • University of Rochester Neurology
    • Ohio
      • Cleveland、Ohio、アメリカ、44195
        • Cleveland Clinic Foundation
      • South Euclid、Ohio、アメリカ、44121
        • University Hospitals Cleveland Medical Center
      • Toledo、Ohio、アメリカ、43614
        • Univerity of Toledo
    • Oregon
      • Portland、Oregon、アメリカ、97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19107
        • Thomas Jefferson University
      • Philadelphia、Pennsylvania、アメリカ、19107
        • Parkinson's Disease and Movement Disorders Cente at University of Pennyslvania
    • South Carolina
      • Charleston、South Carolina、アメリカ、29425
        • MUSC
    • Tennessee
      • Nashville、Tennessee、アメリカ、37232
        • Vanderbilt Medical Center
    • Texas
      • Houston、Texas、アメリカ、77030
        • Baylor College of Medicine
      • San Antonio、Texas、アメリカ、78229
        • University of Texas Health Science Center - San Antonio
    • Utah
      • Salt Lake City、Utah、アメリカ、84107
        • Intermountain Healthcare
    • Washington
      • Kirkland、Washington、アメリカ、98034
        • Evergreen Neuroscience Institute
      • Seattle、Washington、アメリカ、98195
        • University of Washington
      • Spokane、Washington、アメリカ、99202
        • Inland Northwest Research
  • イギリス
      • Dundee、イギリス
        • NHS Tayside-Ninewells Hospital and Medical School
      • Glasgow、イギリス
        • Glasgow Memory Clinic
      • London、イギリス
        • King's College London - David Goldberg Centre
      • Newcastle upon Tyne、イギリス
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital
      • Plymouth、イギリス
        • University Hospitals Plymouth NHS Trust
  • イタリア
      • Bologna、イタリア
        • IRCCS Istituto Delle Scienze Neurologiche DI
      • Brescia、イタリア、25123
        • Spedali Civilia di Brescia
      • Brindisi、イタリア、72100
        • Ospedale Antonio Perrino
      • Milan、イタリア、20133
        • IRCCS Carlo Besta Neurological Institute
      • Milan、イタリア、20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Naples、イタリア、80138
        • Universita degli Studi della Campania Luigi Vanvitelli - Clinica Neurologia I
      • Padova、イタリア、35128
        • Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Neurologica
      • Roma、イタリア、163
        • IRCSS San Raffaele Pisana
      • Rozzano、イタリア、20086
        • Istituto Clinico Humanitas
      • Salerno、イタリア、84125
        • A.O.U. San Giovanni di Dio Ruggi d'Aragona Centro Parkinson- Piano Rialzato Corpo QT
  • オランダ
      • Amsterdam、オランダ
        • Amsterdam Medical Center UMC
      • Groningen、オランダ
        • University Medical Center Groningen
      • Utrecht、オランダ
        • St. Antonius Ziekenhuis (St. Antonius Hospital) - Utrecht
  • カナダ
      • Ottawa、カナダ
        • Ottawa Hospital Research Institute
    • Quebec
      • Gatineau、Quebec、カナダ
        • Clinique Neuro-Outaouais (Neuro-Outaouais Clinic)
      • Montreal、Quebec、カナダ、3801
        • Montreal Neurological Institute & Hospital
  • スウェーデン
      • Lund、スウェーデン、221 85
        • Skane University Hospital, Lund University
      • Uppsala、スウェーデン
        • Neurologmottagningen, QD 62
  • スペイン
      • Badalona、スペイン、08916
        • Hospital Universitari Germans Trias i Pujol
      • Barakaldo、スペイン、48903
        • Hospital Universitario Cruces
      • Barcelona、スペイン、08035
        • Hospital Vall D´Hebron
      • Barcelona、スペイン、08025
        • Hospital de la Santa Creu I Sant Pau
      • Madrid、スペイン、28034
        • Hospital Ruber Internacional
      • Madrid、スペイン、28006
        • Hospital Universitaio de La Princesa
      • Seville、スペイン、41013
        • Hospital Universitario Virgen del Rocio
  • ドイツ
      • Beelitz-Heilstätten、ドイツ、14547
        • Neurologisches Fachkrankenhaus für, Bewegungsstörungen und Parkinson
      • Biskirchen、ドイツ、35638
        • Gertrudis Clinic Biskirchen, Parkinson-Center
      • Kassel、ドイツ、34128
        • Paracelsus-Elena-Klinik
      • Marburg、ドイツ、35039
        • Universitats klinikum Marburg
      • Munich、ドイツ、81377
        • Klinikum der Universität München, Campus Grosshadern, Neurologische Klinik und Poliklinik
      • Munich、ドイツ
        • Ludwig-Maximilians University Munich
      • Wolfach、ドイツ、77709
        • Parkinson-Klinik Ortenau GmbH&Co KG
  • フランス
      • Nantes、フランス
        • CHU de Nantes - Hopital Nord Laennec
      • Nice、フランス、6002
        • CHU de Nice Hopital Pasteur
      • Nîmes、フランス
        • CHU de Nimes
      • Paris、フランス
        • Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Pitie-Salpetriere - Centres d'Investigation Clinique (CIC) Paris-Est
      • Rennes、フランス
        • CHU de Rennes Hopital Pontchaillou
      • Toulouse、フランス
        • Hopital Paule de Viguier
      • Toulouse、フランス
        • CIC Toulouse
  • ポルトガル
      • Coimbra、ポルトガル
        • Centro Hospitalar Universitario de Coimbra
      • Guimarães、ポルトガル、4835-044
        • Hospital Senhora da Oliveira de Guimaraes
      • Porto、ポルトガル、4200-319
        • Hospital S.JOÃO
      • Porto、ポルトガル、4099-001
        • Centro Hospitalar Universitario de Santo Antonio
      • Torres Vedras、ポルトガル
        • CNS - Campus Neurologico
  • ポーランド
      • Bydgoszcz、ポーランド、85-163
        • Centrum Medyczne NEUROMED Sp. z o.o. ul.
      • Krakow、ポーランド、31-505
        • Krakowkska Akademia Neurologii Sp. z o.o
      • Lodz、ポーランド、90-640
        • NeuroKlinika Gabinet Lekarski

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

35年～80年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

Subjects who satisfy all of the following criteria will be eligible for Part A (Genetic Screening) of the study:

  • The subject is ≥35 and ≤80 years of age at the time of informed consent.
  • The subject has a clinical diagnosis of PD for at least 1 year and for no longer than 7 years before initiation of screening (for Part A), as confirmed by a neurologist using the MDS Criteria for Parkinson's Disease.
  • The subject has a modified Hoehn and Yahr score ≤2.5.
  • The subject is receiving symptomatic treatment for PD.
  • The subject is capable of giving signed informed consent.

Subjects who satisfy all the following criteria will be eligible for Part B (Double-Blind Treatment) of the study:

  • Informed Consent - The subject is capable of giving signed informed consent.
  • The subject has a known GBA-PD risk-associated variant (as determined in Part A [Genetic Screening] of this study).
  • The subject has a score ≥22 on the Montreal Cognitive Assessment (MoCA) scale.
  • The subject does not have severe motor fluctuations or disabling dyskinesias in the clinical judgment of the investigator.
  • The subject has been on stable doses of PD medications for at least 30 days (at least 60 days for rasagiline) before initiation of screening in Part B (Double-Blind Treatment).
  • The subject is able to comply with the study restrictions.
  • The subject has a body mass index (BMI) of 18 to 40 kg/m2.
  • If a sexually active man or a women of childbearing potential, the subject agrees to use highly effective birth control or to remain abstinent during the trial and for 30 days after the last dose of IMP. Complete abstinence from sexual intercourse if this is the subject's usual and preferred lifestyle; or sexual partner with surgical sterilization (e.g., tubal ligation, hysterectomy and/or bilateral oophorectomy, vasectomy).

Exclusion Criteria:

• Individuals who do not satisfy the inclusion criteria for Part A (Genetic Screening) will be excluded.

Subjects who meet any of the following criteria for Part B (Double-Blind Treatment) are not eligible for the study.

  • The subject has Gaucher's disease (GD), as defined by clinical signs and symptoms (i.e., hepatosplenomegaly, cytopenia, skeletal disease), and/or a medical history of marked deficiency of GCase activity compatible with GD.
  • The subject is homozygous for a GBA1 pathogenic variant that is known to be associated with GD or compound heterozygous for 2 alleles that are known to be associated with GD.
  • The subject carries a known PD-associated LRRK2 pathogenic variant.
  • The subject has atypical or secondary parkinsonism by medical history or in the opinion of the investigator. Atypical parkinsonism includes, but is not limited to, diagnoses of progressive supranuclear palsy, cortico-basal syndrome, and multiple system atrophy. Secondary parkinsonism includes drug-induced, toxin-induced, postinfectious, posttraumatic, or vascular parkinsonism.
  • The subject has a history of (within 60 days before initiation of screening) or has planned upcoming major surgery that could interfere with, or for which the treatment might interfere with, the conduct of the study or that would pose an unacceptable risk to the subject in the opinion of the investigator.
  • The subject has any active or chronic disease or condition other than PD that could interfere with, or for which the treatment might interfere with, the conduct of the study or pose an unacceptable risk to the subject in the opinion of the investigator based on medical history, physical examination, vital signs, 12-lead ECG, or clinical laboratory tests. Minor deviations of laboratory values from the normal range may be acceptable if judged by the investigator to have no/minor clinical relevance.
  • The subject has a recent history (last 6 months) of abuse of addictive substances (alcohol, illegal substances), currently uses >21 units of alcohol per week, or is a regular recreational user of sedatives, hypnotics, tranquillizers, or any other addictive agent in the opinion of the investigator.
  • The subject has a positive test for drugs of abuse at screening or before administration of the first dose of investigational medicinal product (IMP) that the investigator judges as clinically relevant. A positive test for tetrahydrocannabinol (THC) is exclusionary. A positive test for cannabinoids (not containing THC) is not exclusionary if the subject is a recreational user (not an abuser) of cannabinoids, in the opinion of the investigator, and agrees to abstain from using cannabinoids within 12 hours before study visits. A positive drug screen that is attributed to an allowed prescription drug is not exclusionary but should be agreed with the medical monitor.
  • The subject is currently pregnant, is planning pregnancy within the timeframe of the study, or is breastfeeding.
  • The subject is using a strong inhibitors and inducers CYP3A4 at the time of screening for Part B (Double-Blind Treatment).
  • The subject is using a breast cancer resistance protein (BCRP) substrate (e.g., pravastatin, rosuvastatin, glyburide) at the time of screening for Part B (Double-Blind Treatment).
  • The subject has used any of the following medications within 60 days before Baseline: typical or atypical antipsychotics (including, but not limited to, clozapine, pimavanserin, olanzapine, risperidone, and aripiprazole), metoclopramide, prochlorperazine, methyldopa, tetrabenazine, deutetrabenazine, valbenazine, or reserpine.
  • The subject has received a vaccination within 14 days before administration of the first dose of IMP.
  • The subject has a prior history of or there is a plan to conduct deep brain stimulation (DBS), lesional procedures, (i.e., thalamotomy), or focused ultrasound; to initiate gene therapy treatment for PD; or to initiate use of any formulation of intestinal infusion or continuous subcutaneous infusion of PD medications.
  • The subject is currently participating in or has participated in an investigational drug study within 3 months or 5 half-lives, whichever is longer; in a therapeutic device study within 3 months before the first dose of IMP; or has previously participated in a gene therapy trial. Concurrent participation in an observational study is acceptable.
  • The subject has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), or human immunodeficiency virus 1 (HIV-1) or 2 (HIV-2) at screening. If reflex testing for hepatitis B or HCV DNA is negative, the subject may be eligible for the study.
  • The subject has renal insufficiency as defined by an estimated glomerular filtration rate (eGFR) of <60 mL/min at screening.
  • The subject has cirrhosis (Child-Pugh A, B, or C) or any of the following laboratory values at screening: serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of normal (ULN) or bilirubin >2 × ULN except if the subject has known or suspected Gilbert's disease.
  • The subject has a QT interval corrected for heart rate by Fridericia's method (QTcF) value >450 msec if male or >470 msec if female at screening.
  • The subject provides a positive response on Question 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) based on the last 6 months or, in the opinion of the investigator, presents a serious risk of suicide at screening.
  • The subject had a positive severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2) test (any type) result within the 30 days before signing informed consent for Part B (Double-Blind Treatment) or has 2 or more current symptoms (e.g., sore throat, cough, fever) at the same time that are consistent with the Coronavirus disease 2019 (COVID-19) infection (not tested) in the opinion of the investigator.
  • The subject has a clinical history that is consistent with a previous COVID-19 infection and has not recovered fully, maintaining nonspecific symptoms like, for example, fatigue, shortness of breath, difficulty concentrating, sleep disorders, fever, anxiety, and depression.
  • The subject has previously received BIA 28-6156 or has a known allergy or hypersensitivity to BIA 28-6156 or any components of the formulation.
  • The subject is an unsuitable candidate to receive BIA 28-6156 or is unable or unlikely to comply with the dosing schedule or study evaluations in the judgment of the investigator.

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：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：Placebo

Placebo
薬：Placebo

Placebo, once daily, oral administration.
実験的：BIA 28-6156 10 mg

Participants will be randomized to receive BIA 28-6156 10 mg during the Treatment Period.
薬：BIA 28-6156 10 mg

BIA 28-6156 10 mg, once daily, oral administration.
実験的：BIA 28-6156 60 mg

Participants will be randomized to receive BIA 28-6156 60 mg during the Treatment Period.
薬：BIA 28-6156 60 mg

BIA 28-6156 60 mg, once daily, oral administration.

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
Time from baseline to clinically meaningful progression on motor aspects of experiences of daily living (assessed by MDS-UPDRS Part II score and MDS-UPDRS Part III score)
時間枠：From Baseline up to Week 78

Time from baseline to clinically meaningful progression on motor aspects of experiences of daily living, as assessed by ≥2-point increase from baseline in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II score and no improvement in the Motor Examination, as assessed by ≥0-point increase from baseline in MDS-UPDRS Part III score. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assesses motor experiences of daily living (Range 0-52). It contains 13 questions which are to be rated by the patient and/or caregiver. Part III assesses the motor signs of PD and is rated by the investigator (Range 0-132). Part III contains 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicates more severe symptoms of PD.
From Baseline up to Week 78

二次結果の測定

結果測定
メジャーの説明
時間枠
Time from baseline to clinically meaningful progression on motor signs of the disease (assessed by MDS-UPDRS Part III score)
時間枠：From Baseline up to Week 78

Time from baseline to clinically meaningful progression on motor signs of the disease, as assessed by a ≥5-point increase from baseline in the MDS-UPDRS Part III score. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part III assesses the motor signs of PD and is rated by the investigator (Range 0-132). Part III contains 33 scores based on 18 items. A higher score indicates more severe symptoms of PD.
From Baseline up to Week 78
Time from baseline to any worsening on the Clinical Global Impression - Change (CGI-C) scale
時間枠：From Baseline up to Week 78

The Clinical Global Impression of Change (CGI-C) is a scale used to assess the overall clinical improvement or worsening of a patient's condition over time. The CGI-C scale ranges from 1 to 7, with lower scores indicating greater improvement (1 - Very much improved, 2 - Much improved, 3 - Minimally improved, 4 - No change, 5 - Minimally worse, 6 - Much worse, 7 - Very much worse).
From Baseline up to Week 78
Time from baseline to any worsening on the Patient Global Impression - Change (PGI-C) scale
時間枠：From Baseline up to Week 78

The Patient Global Impression of Change (PGI-C) is a self-report tool used to assess a patient's perception of their overall improvement or worsening in a particular health-related domain over time. The PGI-C scale asks patients to rate their overall improvement or worsening since the start of treatment on a seven-point scale, with lower scores indicating greater improvement (1 - Very much improved, 2 - Much improved, 3 - Minimally improved, 4 - No change, 5 - Minimally worse, 6 - Much worse, 7 - Very much worse)
From Baseline up to Week 78
Change from Baseline to Week 78 in the MDS-UPDRS Total (Part I-IV) score
時間枠：From Baseline up to Week 78

The MDS-UPDRS assesses nonmotor and motor experiences of daily living, motor examination, and motor complication categories. The MDS-UPDRS Part I-IV total score was calculated as the sum of the individual item scores from these categories. Each item is rated on a scale from 0 to 4 on which 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. A higher score indicates more severe symptoms of PD.
From Baseline up to Week 78
Change from Baseline to Week 78 in the Modified Hoehn and Yahr score
時間枠：From Baseline up to Week 78

The Modified Hoehn and Yahr scale measures the severity of Parkinson's disease by assessing the patient's motor symptoms and functional impairment. The scale has seven stages, ranging from 1 to 5, with higher scores indicating more severe disease. (1 - Unilateral involvement only; 1.5 - Unilateral and axial involvement; 2 - Bilateral involvement without impairment of balance; 2.5 - Mild bilateral disease with recovery on pull test; 3 - Mild to moderate bilateral disease; some postural instability; physically independent; 4 - Severe disability; still able to walk or stand unassisted; 5 - Wheelchair bound or bedridden unless added).
From Baseline up to Week 78
Change from Baseline to Week 78 in the 39-Item Parkinson's Disease Questionnaire (PDQ-39) score
時間枠：From Baseline up to Week 78

The PDQ-39 is the most thoroughly validated and extensively used self-report measure for the assessment of health-related quality of life in patients with PD. The questionnaire measures 39 items, which assess 8 domains of health: mobility (10 items), activities of daily living (6 items), emotional well being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communication (3 items), and bodily discomfort (3 items). Each item is scored on the following scale: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = always. Items in each subscale and the total scale can be summarized into an index and transformed linearly to a scale from 0 (perfect health as assessed by the measure) to 100 (worst health as assessed by the measure).
From Baseline up to Week 78

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。

スポンサー

Bial R&D Investments, S.A.

捜査官

  • スタディディレクター：Raquel Costa、Bial R&D Investments, S.A.

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)

2023年3月31日

一次修了 (実際)

2026年4月2日

研究の完了 (実際)

2026年9月9日

試験登録日

最初に提出

2023年4月6日

QC基準を満たした最初の提出物

2023年4月18日

最初の投稿 (実際)

2023年4月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月6日

QC基準を満たした最後の更新が送信されました

2026年11月5日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • BIA 28-6156-201
  • 2022-501783-18-00 (その他の識別子：EU Trial Number)

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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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