A Study of TAK-341 in Treatment of Multiple System Atrophy
Multiple System Atrophy
About this trial
This is an interventional treatment trial for Multiple System Atrophy focused on measuring Drug Therapy
Eligibility Criteria
Inclusion criteria:
Diagnostic:
- The participant has a diagnosis of possible or probable MSA using the modified Gilman et al, 2008 diagnostic criteria.
- The participant's onset of first MSA symptoms occurred ≤4 years before screening, as assessed by the investigator.
- Evidence of MSA specific symptoms and deficits as measured by the UMSARS scale.
Exclusion criteria:
Medical History:
1. The participant has any contraindication to study procedures.
Diagnostic Assessments:
- Presence of confounding diagnosis and/or conditions that could affect participant's safety during the study per investigator judgement.
- The participant's participation in a previous study of a disease-modifying therapy (with proven receipt of active treatment) will compromise the interpretability of the data from the present study, per consultation with medical monitor or designee.
Other:
1. The participant has participated in another study investigating active or passive immunization against α-synuclein (αSYN) for progressive disease (PD) or MSA, or has had immunoglobulin G therapy, within 6 months before screening.
Sites / Locations
- UAMS Health - Movement Disorders ClinicRecruiting
- UCLA Neurological Services
- AdventHealth Innovation Tower
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center - 330 Brookline Ave
- Quest Research Institute - Alcanza - HyperCoreRecruiting
- Mayo ClinicRecruiting
- NYU Langone HealthRecruiting
- Duke University School of MedicineRecruiting
- The Cleveland Clinic FoundationRecruiting
- University of Texas Southwestern Medical CenterRecruiting
- Baylor College of Medicine
- Inland Northwest ResearchRecruiting
- Medizinische Universitat GrazRecruiting
- Medizinische Universitat Innsbruck
- Bispebjerg HospitalRecruiting
- Aarhus UniversitetshospitalRecruiting
- Hopitaux de La TimoneRecruiting
- Hopital PurpanRecruiting
- Hopitaux Universitaires de Strasbourg
- Universitatsklinikum Tubingen
- Universitatsklinikum Ulm
- Klinikum Groshadern, LMU
- Paracelsus-Elena-Klinik KasselRecruiting
- Universitatsklinikum Giesen und Marburg GmbHRecruiting
- Medizinische Hochschule HannoverRecruiting
- Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB) - St. Josef-HospitalRecruiting
- Deutsches Zentrum fur Neurodegenerative ErkrankungRecruiting
- Universitatsklinikum MunsterRecruiting
- Universitatsklinikum Carl Gustav Carus an der TU DresdenRecruiting
- Universitatsklinikum LeipzigRecruiting
- Charite - Universitatsmedizin BerlinRecruiting
- Ospedale BellariaRecruiting
- IRCCS San Raffaele Roma
- Fondazione IRCCS Ca Granda Ospedale Maggiore PoliclinicoRecruiting
- Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta
- Istituto Clinico HumanitasRecruiting
- Azienda Ospedale Universita Padova
- Fondazione Istituto Neurologico Mondino IRCCS
- Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi dAragonaRecruiting
- Hokkaido University HospitalRecruiting
- Kyoto University Hospital
- Chiba University Hospital
- The University of Tokyo HospitalRecruiting
- Medical Hospital of Tokyo Medical and Dental University
- National Center of Neurology and Psychiatry
- Campus Neurologico Senior
- Hospital Pedro HispanoRecruiting
- Hospital de Santa Maria-Avenida Prof. Egas Moniz
- Hospital Universitario CrucesRecruiting
- Hospital Universitario Vall d'HebronRecruiting
- Hospital de La Santa Creu i Sant PauRecruiting
- Hospital Universitario de La PrincesaRecruiting
- Hospital Universitario Ramon y CajalRecruiting
- Hospital Universitari i Politecnic La Fe de ValenciaRecruiting
- Southampton General HospitalRecruiting
- Newcastle UniversityRecruiting
- The National Hospital for Neurology and NeurosurgeryRecruiting
- Derriford Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Early PK Cohort: TAK-341 Dose 1
Early PK Cohort: Placebo
Main Cohort: TAK-341 Dose 2
Main Cohort: Placebo
Participants will be randomized to receive TAK-341 at a starting Dose 1 at 4 week intervals for up to 52 weeks.
Participants will be randomized to receive TAK-341 placebo, up to 52 weeks.
Participants will be randomized to receive TAK-341 at a starting Dose 2 at 4 week intervals for up to 52 weeks.
Participants will be randomized to receive TAK-341 placebo, up to 52 weeks.