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A Study of TAK-341 in Treatment of Multiple System Atrophy

Primary Purpose

Multiple System Atrophy

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TAK-341
Placebo
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple System Atrophy focused on measuring Drug Therapy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Diagnostic:

  1. The participant has a diagnosis of possible or probable MSA using the modified Gilman et al, 2008 diagnostic criteria.
  2. The participant's onset of first MSA symptoms occurred ≤4 years before screening, as assessed by the investigator.
  3. 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:

  1. Presence of confounding diagnosis and/or conditions that could affect participant's safety during the study per investigator judgement.
  2. 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

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Early PK Cohort: TAK-341 Dose 1

Early PK Cohort: Placebo

Main Cohort: TAK-341 Dose 2

Main Cohort: Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

Change from Baseline in a Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I at Week 52
UMSARS Part I (historical review) is a 11-item scale that was adapted from the Unified Parkinson's Disease Rating Scale (UPDRS) and is used to assess activities related to motor disability and related to autonomic dysfunction. Each item is scored from 1 (normal) to 4 (severe). The total score is a sum of scores from all domains and can range from 11 to 44. Higher scores mean poorer health.

Secondary Outcome Measures

Cmax: Maximum Observed Serum Concentration for TAK-341
Tmax: Time of First Occurrence of Cmax in Serum for TAK-341
AUCτ: Area Under the Concentration-time Curve During a Dosing Interval in Serum for TAK-341
Cerebrospinal Fluid (CSF) Concentration of TAK-341
Lumbar puncture for CSF sampling will be performed.
Change From Baseline in 11-item UMSARS at Week 52
The 11- item UMSARS includes 11 items from Part I and II to assesses both motor and autonomic disability. UMSARS Part I (historical review) is used to assess activities related to motor disability and autonomic dysfunction. UMSARS Part II (motor examination) is used to measure the functional impairment and specific parkinsonian or cerebellar features. Each item is scored from 0 (normal) to 4 (severe). The total score is a sum of scores from all domains and can range from 0 to 44. Higher scores mean poorer health.
Change From Baseline in UMSARS Total Score at Week 52
UMSARS total scale consists of all items from UMSARS Parts I and II. UMSARS Part I (historical review): 12-item scale used to assess activities related to motor disability and autonomic dysfunction.Each item is scored from 0 (normal) to 4 (severe).UMSARS Part II (motor examination): 14-item scale used to measure the functional impairment (eg, speech, rapid alternating movements of the hands, finger taps, leg agility) of selected complex movements, and specific parkinsonian (tremor at rest) or cerebellar (ocular motor dysfunction, heel-shin test) features. Each item is scored from 0 (normal) to 4 (severe).
Change From Baseline in UMSARS Part I at Week 52
UMSARS Part I (historical review) is a modified 11-item scale that was adapted from the UPDRS and is used to assess activities related to motor disability (first 8 items) and 4 novel items related to autonomic dysfunction. Each item is scored from 0 (normal) to 4 (severe). The total score is a sum of scores from all items and can range from 0 to 44. Higher scores mean poorer health.
Change From Baseline in UMSARS Part II at Week 52
UMSARS Part II (motor examination) is a 14-item scale. Most of the items (e.g., speech, rapid alternating movements of the hands, finger taps, leg agility) measure the functional impairment of selected complex movements, and only a few items directly refer to specific parkinsonian (tremor at rest) or cerebellar (ocular motor dysfunction, heel-shin test) features. The motor examination section of UMSARS was based on modified UPDRS-III items in addition to novel items such as heel-knee-shin ataxia. Each item is scored from 0 (normal) to 4 (severe). The total score is a sum of scores from all items and can range from 0 to 56. Higher scores mean poorer health.
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score
The CGI-S is used to assess the clinician's impression of the participant's clinical condition. The clinician should use his or her total clinical experience with this participant population and rate the current severity of the participant's illness on a 7-point scale ranging from 1 for normal, not at all ill to 7 for among the most extremely ill participants. Higher scores mean better health.
Change From Baseline in Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT) Total Score
The SCOPA-AUT is a patient-reported outcome that assesses autonomic function. Autonomic function is a critical symptom domain for MSA. The scale is self-completed by participants and consists of 25 items assessing the following domains: gastrointestinal (7 items), urinary (6 items), cardiovascular (3 items), thermoregulatory (4 items), pupillomotor (1 item), and sexual (2 items for men and 2 items for women). The score for each item ranges from 0 (never experiencing the symptom) to 3 (often experiencing the symptom). The total composite score including all domains will be reported. The score range is 0 (no symptoms) to 69 (highest burden of symptoms).
Overall Survival (OS)
OS is defined as time from the first day of study drug administration to death due to any cause.
Number of Participants With at Least one Adverse Event (AE)
An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. Data will be reported for number of participants to be analyzed for safety parameters that will include clinically significant abnormal values for clinical laboratory evaluations, vital signs, ECG parameters, physical examination, neurological examination and Columbia-Suicide Severity Rating Scale (C-SSRS).
Number of Participants With Antidrug Antibody

Full Information

First Posted
September 1, 2022
Last Updated
October 23, 2023
Sponsor
Takeda
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT05526391
Brief Title
A Study of TAK-341 in Treatment of Multiple System Atrophy
Official Title
A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous TAK-341 in Subjects With Multiple System Atrophy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2022 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main aim is to see how TAK-341 works after 52 weeks in participants with multiple system atrophy as measured by the Unified Multiple System Atrophy Rating Scale Part I (UMSARS). The study will enroll approximately 138 patients. Participants will receive a total of 13 intravenous infusions every 4 weeks approximately, these may be either of TAK-341 or placebo, after each infusion some blood samplings will be taken and other assessments completed. This trial will be conducted in North America, Europe and Asia.
Detailed Description
The drug being tested in this study is called TAK-341. The study will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of intravenous (IV) TAK-341 in participants with multiple system atrophy (MSA). The study will enroll approximately 138 participants. The study comprises a screening period of up to 42 days (6 weeks), a 52-week double-blind treatment period, and a follow-up safety visit. Participants will be randomly assigned (by chance, like flipping a coin) to one of the treatment schedules-which will remain undisclosed to the participant, care provider and investigator during the study: Early PK Cohort: TAK-341 Dose 1 Early PK Cohort: Placebo Main Cohort: TAK-341 Dose 2 Main Cohort: Placebo The change from baseline in UMSARS will be measured at Week 52 post-dose. This multi-center trial will be conducted worldwide. The duration of treatment in this study will be 52 weeks. Participants will make a follow-up visit to the site after approximately 90 days after the last dose of study treatment. Early-termination participants will not make a follow-up safety visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple System Atrophy
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early PK Cohort: TAK-341 Dose 1
Arm Type
Experimental
Arm Description
Participants will be randomized to receive TAK-341 at a starting Dose 1 at 4 week intervals for up to 52 weeks.
Arm Title
Early PK Cohort: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be randomized to receive TAK-341 placebo, up to 52 weeks.
Arm Title
Main Cohort: TAK-341 Dose 2
Arm Type
Experimental
Arm Description
Participants will be randomized to receive TAK-341 at a starting Dose 2 at 4 week intervals for up to 52 weeks.
Arm Title
Main Cohort: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be randomized to receive TAK-341 placebo, up to 52 weeks.
Intervention Type
Drug
Intervention Name(s)
TAK-341
Other Intervention Name(s)
MEDI1341
Intervention Description
TAK-341 IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
TAK-341 placebo-matching IV infusion
Primary Outcome Measure Information:
Title
Change from Baseline in a Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I at Week 52
Description
UMSARS Part I (historical review) is a 11-item scale that was adapted from the Unified Parkinson's Disease Rating Scale (UPDRS) and is used to assess activities related to motor disability and related to autonomic dysfunction. Each item is scored from 1 (normal) to 4 (severe). The total score is a sum of scores from all domains and can range from 11 to 44. Higher scores mean poorer health.
Time Frame
Up to 52 weeks
Secondary Outcome Measure Information:
Title
Cmax: Maximum Observed Serum Concentration for TAK-341
Time Frame
Pre-dose on Days 1, 29, 57, 85, 169, 253, 337; at multiple timepoints (up to 24 hours) post-dose on Days 1, 57, 85, 169, 337; anytime once on Days 365, 427 or at early termination (Day 85 applicable to only early PK cohorts)
Title
Tmax: Time of First Occurrence of Cmax in Serum for TAK-341
Time Frame
Pre-dose on Days 1, 29, 57, 85, 169, 253, 337; at multiple timepoints (up to 24 hours) post-dose on Days 1, 57, 85, 169, 337; anytime once on Days 365, 427 or at early termination (Day 85 applicable to only early PK cohorts)
Title
AUCτ: Area Under the Concentration-time Curve During a Dosing Interval in Serum for TAK-341
Time Frame
Pre-dose on Days 1, 29, 57, 85, 169, 253, 337; at multiple timepoints (up to 24 hours) post-dose on Days 1, 57, 85, 169, 337; anytime once on Days 365, 427 or at early termination (Day 85 applicable to only early PK cohorts)
Title
Cerebrospinal Fluid (CSF) Concentration of TAK-341
Description
Lumbar puncture for CSF sampling will be performed.
Time Frame
Pre-dose on Days 1, 85 (applicable to only early PK cohorts), and 365
Title
Change From Baseline in 11-item UMSARS at Week 52
Description
The 11- item UMSARS includes 11 items from Part I and II to assesses both motor and autonomic disability. UMSARS Part I (historical review) is used to assess activities related to motor disability and autonomic dysfunction. UMSARS Part II (motor examination) is used to measure the functional impairment and specific parkinsonian or cerebellar features. Each item is scored from 0 (normal) to 4 (severe). The total score is a sum of scores from all domains and can range from 0 to 44. Higher scores mean poorer health.
Time Frame
Up to 52 weeks
Title
Change From Baseline in UMSARS Total Score at Week 52
Description
UMSARS total scale consists of all items from UMSARS Parts I and II. UMSARS Part I (historical review): 12-item scale used to assess activities related to motor disability and autonomic dysfunction.Each item is scored from 0 (normal) to 4 (severe).UMSARS Part II (motor examination): 14-item scale used to measure the functional impairment (eg, speech, rapid alternating movements of the hands, finger taps, leg agility) of selected complex movements, and specific parkinsonian (tremor at rest) or cerebellar (ocular motor dysfunction, heel-shin test) features. Each item is scored from 0 (normal) to 4 (severe).
Time Frame
Up to 52 weeks
Title
Change From Baseline in UMSARS Part I at Week 52
Description
UMSARS Part I (historical review) is a modified 11-item scale that was adapted from the UPDRS and is used to assess activities related to motor disability (first 8 items) and 4 novel items related to autonomic dysfunction. Each item is scored from 0 (normal) to 4 (severe). The total score is a sum of scores from all items and can range from 0 to 44. Higher scores mean poorer health.
Time Frame
Up to 52 weeks
Title
Change From Baseline in UMSARS Part II at Week 52
Description
UMSARS Part II (motor examination) is a 14-item scale. Most of the items (e.g., speech, rapid alternating movements of the hands, finger taps, leg agility) measure the functional impairment of selected complex movements, and only a few items directly refer to specific parkinsonian (tremor at rest) or cerebellar (ocular motor dysfunction, heel-shin test) features. The motor examination section of UMSARS was based on modified UPDRS-III items in addition to novel items such as heel-knee-shin ataxia. Each item is scored from 0 (normal) to 4 (severe). The total score is a sum of scores from all items and can range from 0 to 56. Higher scores mean poorer health.
Time Frame
Up to 52 weeks
Title
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score
Description
The CGI-S is used to assess the clinician's impression of the participant's clinical condition. The clinician should use his or her total clinical experience with this participant population and rate the current severity of the participant's illness on a 7-point scale ranging from 1 for normal, not at all ill to 7 for among the most extremely ill participants. Higher scores mean better health.
Time Frame
Up to 52 weeks
Title
Change From Baseline in Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT) Total Score
Description
The SCOPA-AUT is a patient-reported outcome that assesses autonomic function. Autonomic function is a critical symptom domain for MSA. The scale is self-completed by participants and consists of 25 items assessing the following domains: gastrointestinal (7 items), urinary (6 items), cardiovascular (3 items), thermoregulatory (4 items), pupillomotor (1 item), and sexual (2 items for men and 2 items for women). The score for each item ranges from 0 (never experiencing the symptom) to 3 (often experiencing the symptom). The total composite score including all domains will be reported. The score range is 0 (no symptoms) to 69 (highest burden of symptoms).
Time Frame
Up to 52 weeks
Title
Overall Survival (OS)
Description
OS is defined as time from the first day of study drug administration to death due to any cause.
Time Frame
Up to 52 weeks
Title
Number of Participants With at Least one Adverse Event (AE)
Description
An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. Data will be reported for number of participants to be analyzed for safety parameters that will include clinically significant abnormal values for clinical laboratory evaluations, vital signs, ECG parameters, physical examination, neurological examination and Columbia-Suicide Severity Rating Scale (C-SSRS).
Time Frame
Up to 52 weeks
Title
Number of Participants With Antidrug Antibody
Time Frame
Up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeda Contact
Phone
+1-877-825-3327
Email
medinfoUS@takeda.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
UAMS Health - Movement Disorders Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
501-526-5364
Email
rdhall@uams.edu
First Name & Middle Initial & Last Name & Degree
Rohit Dhall
Facility Name
UCLA Neurological Services
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
310-720-6815
Ext
3
Email
sperlman@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Susan Perlman
Facility Name
AdventHealth Innovation Tower
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
407-303-6729
Email
anwar.ahmed.md@adventhealth.com
First Name & Middle Initial & Last Name & Degree
Anwar Ahmed
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
888-888-8888
Email
jschmahmann@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Jeremy Schmahmann
Facility Name
Beth Israel Deaconess Medical Center - 330 Brookline Ave
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
617-632-8454
Email
rfreeman@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Roy Freeman
Facility Name
Quest Research Institute - Alcanza - HyperCore
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
248-957-8940
Email
aaron@questri.com
First Name & Middle Initial & Last Name & Degree
Aaron Ellenbogen
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
507-284-0336
Email
adcresearch@mayo.edu
First Name & Middle Initial & Last Name & Degree
Phillip Low
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
212-263-7225
Email
patricio.millar@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Patricio Millar Vernetti
Facility Name
Duke University School of Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
919-681-3012
Email
vera.george@duke.edu
First Name & Middle Initial & Last Name & Degree
Sneha Mantri
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
216-444-9715
Email
ashtonj@ccf.org
First Name & Middle Initial & Last Name & Degree
Michal Gostkowski
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
214-648-8816
Email
steven.vernino@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Steven Vernino
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
713-798-9999
Email
stbellow@bcm.edu
First Name & Middle Initial & Last Name & Degree
Steven Bellows
Facility Name
Inland Northwest Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
509-960-2818
Email
contact@inwresearch.com
First Name & Middle Initial & Last Name & Degree
Jason Aldred
Facility Name
Medizinische Universitat Graz
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4331638583379
Email
petra.schwingenschuh@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Petra Schwingenschuh
Facility Name
Medizinische Universitat Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4351250481498
Email
Klaus.Seppi@tirol-kliniken.at
First Name & Middle Initial & Last Name & Degree
Klaus Seppi
Facility Name
Bispebjerg Hospital
City
Kobenhavn NV
State/Province
Capital
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4561785332
Email
anne-mette.hejl.01@regionh.dk
First Name & Middle Initial & Last Name & Degree
Anne-Mette Hejl
Facility Name
Aarhus Universitetshospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4523886664
Email
memoel@rm.dk
First Name & Middle Initial & Last Name & Degree
Mette Moeller
Facility Name
Hopitaux de La Timone
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+33491384333
Email
alexandre.eusebio@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Alexandre Eusebio
Facility Name
Hopital Purpan
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+33561779103
Email
olivier.rascol@univ-tlse3.fr
First Name & Middle Initial & Last Name & Degree
Olivier Rascol
Facility Name
Hopitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+33388128531
Email
christine.tranchant@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Christine Tranchant
Facility Name
Universitatsklinikum Tubingen
City
Tubingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4970712982048
Email
thomas.gasser@uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Thomas Gasser
Facility Name
Universitatsklinikum Ulm
City
Ulm
State/Province
Baden-Wurttemberg
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+497311771206
Email
jan.kassubek@uni-ulm.de
First Name & Middle Initial & Last Name & Degree
Jan Kassubek
Facility Name
Klinikum Groshadern, LMU
City
Munchen
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+498944006464
Email
guenter.hoeglinger@dzne.de
First Name & Middle Initial & Last Name & Degree
Gunter Hoglinger
Facility Name
Paracelsus-Elena-Klinik Kassel
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34128
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4956160090
Email
brit.mollenhauer@med.uni-goettingen.de
First Name & Middle Initial & Last Name & Degree
Brit Mollenhauer
Facility Name
Universitatsklinikum Giesen und Marburg GmbH
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35043
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4964215865168
Email
eggert@med.uni-marburg.de
First Name & Middle Initial & Last Name & Degree
Karla Eggert
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+495115323110
Email
wegner.florian@mh-hannover.de
First Name & Middle Initial & Last Name & Degree
Florian Wegner
Facility Name
Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB) - St. Josef-Hospital
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+492345092703
Email
lars.toenges@rub.de
First Name & Middle Initial & Last Name & Degree
Lars Toenges
Facility Name
Deutsches Zentrum fur Neurodegenerative Erkrankung
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4922828731283
Email
Marcus.Grobe-Einsler@dzne.de
First Name & Middle Initial & Last Name & Degree
Marcus Grobe-Einsler
Facility Name
Universitatsklinikum Munster
City
Munster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+492518346081
Email
inga.claus@ukmuenster.de
First Name & Middle Initial & Last Name & Degree
Inga Claus
Facility Name
Universitatsklinikum Carl Gustav Carus an der TU Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+493514582532
Email
Bjoern.Falkenburger@uniklinikum-dresden.de
First Name & Middle Initial & Last Name & Degree
Bjorn Falkenburger
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+493419724202
Email
jost-julian.rumpf@uniklinik-leipzig.de
First Name & Middle Initial & Last Name & Degree
Jost-Julian Rumpf
Facility Name
Charite - Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4930450660454
Email
patricia.krause@charite.de
First Name & Middle Initial & Last Name & Degree
Patricia Krause
Facility Name
Ospedale Bellaria
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40139
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390512092929
Email
pietro.cortelli@unibo.it
First Name & Middle Initial & Last Name & Degree
Pietro Cortelli
Facility Name
IRCCS San Raffaele Roma
City
Roma
State/Province
Lazio
ZIP/Postal Code
00163
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390652252311
Email
fabrizio.stocchi@sanraffaele.it
First Name & Middle Initial & Last Name & Degree
Fabrizio Stocchi
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390255033807
Email
alessio.difonzo@policlinico.mi.it
First Name & Middle Initial & Last Name & Degree
Alessio Di Fonzo
Facility Name
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390223942552
Email
roberto.eleopra@istituto-besta.it
First Name & Middle Initial & Last Name & Degree
Roberto Eleopra
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390282246477
Email
alberto.albanese@humanitas.it
First Name & Middle Initial & Last Name & Degree
Alberto Albanese
Facility Name
Azienda Ospedale Universita Padova
City
Padova
State/Province
Veneto
ZIP/Postal Code
35126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390412207554
Email
angelo.antonini@unipd.it
First Name & Middle Initial & Last Name & Degree
Angelo Antonini
Facility Name
Fondazione Istituto Neurologico Mondino IRCCS
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390382380221
Email
claudio.pacchetti@mondino.it
First Name & Middle Initial & Last Name & Degree
Claudio Pacchetti
Facility Name
Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi dAragona
City
Salerno
ZIP/Postal Code
84131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+393989673703
Email
mpellecchia@unisa.it
First Name & Middle Initial & Last Name & Degree
Maria Pellecchia
Facility Name
Hokkaido University Hospital
City
Sapporo-Shi
State/Province
Hokkaido
ZIP/Postal Code
060-8638
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81117161161
Email
yabe@med.hokudai.ac.jp
First Name & Middle Initial & Last Name & Degree
Ichiro Yabe
Facility Name
Kyoto University Hospital
City
Kyoto-Shi
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81757513111
Email
ryosuket@kuhp.kyoto-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Ryosuke Takahashi
Facility Name
Chiba University Hospital
City
Chuo-ku
State/Province
Tiba
ZIP/Postal Code
260-8677
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
81432227171
Email
kuwabara-s@faculty.chiba-u.jp
First Name & Middle Initial & Last Name & Degree
Satoshi Kuwabara
Facility Name
The University of Tokyo Hospital
City
Bunkyo-Ku
State/Province
Tokyo
ZIP/Postal Code
113-0033
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81338155411
Email
toda@m.u-tokyo.ac.jp
First Name & Middle Initial & Last Name & Degree
Tatsushi Toda
Facility Name
Medical Hospital of Tokyo Medical and Dental University
City
Bunkyo-Ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81338136111
Email
ishiguro.nuro@tmd.ac.jp
First Name & Middle Initial & Last Name & Degree
Taro Ishiguro
Facility Name
National Center of Neurology and Psychiatry
City
Kodaira-Shi
State/Province
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81423412711
Email
yuji.takahashi@nih.gov
First Name & Middle Initial & Last Name & Degree
Yuji Takahashi
Facility Name
Campus Neurologico Senior
City
Loures
State/Province
Lisboa
ZIP/Postal Code
2674-514
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+351219847200
Email
rita.moiron.simoes@hospitaldaluz.pt
First Name & Middle Initial & Last Name & Degree
Rita Simoes
Facility Name
Hospital Pedro Hispano
City
Senhora Da Hora
State/Province
Porto
ZIP/Postal Code
4464-513
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+351963833391
Email
margarida.calejo@ulsm.min-saude.pt
First Name & Middle Initial & Last Name & Degree
Margarida Calejo
Facility Name
Hospital de Santa Maria-Avenida Prof. Egas Moniz
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+351217805000
Email
miguel.soarescoelho@chln.min-saude.pt
First Name & Middle Initial & Last Name & Degree
Miguel Coelho
Facility Name
Hospital Universitario Cruces
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34946006000ext7961
Email
juancarlos.gomezesteban@osakidetza.eus
First Name & Middle Initial & Last Name & Degree
Juan Carlos Gomez Esteban
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34932746235
Email
jorherna@vhebron.net
First Name & Middle Initial & Last Name & Degree
Jorge Hernandez-Vara
Facility Name
Hospital de La Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34649142360
Email
jpagonabarraga@santpau.cat
First Name & Middle Initial & Last Name & Degree
Javier Pagonbarraga Mora
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
34 915202416
Email
ctm.hlpr@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Lydia Lopez
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34913368000
Email
jlsendon@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Jose Luis Lopez-Sendon Moreno
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34961244164
Email
martinez_ire@gva.es
First Name & Middle Initial & Last Name & Degree
Irene Martinez
Facility Name
Southampton General Hospital
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4407947242022
Email
boyd.ghosh@uhs.nhs.uk
First Name & Middle Initial & Last Name & Degree
Boyd Ghosh
Facility Name
Newcastle University
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE4 5PL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+442033111234
Email
nicola.pavese@newcastle.ac.uk
First Name & Middle Initial & Last Name & Degree
Nicola Pavese
Facility Name
The National Hospital for Neurology and Neurosurgery
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
442034483079
Email
scott.johnstone@nhs.net
First Name & Middle Initial & Last Name & Degree
Scott Johnstone
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4401752432842
Email
s.mullin@nhs.net
First Name & Middle Initial & Last Name & Degree
Stephen Mullin

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/e0316361bd7044cd?idFilter=%5B%22TAK-341-2001%22%5D
Description
To obtain more information about this study, click this link.

Learn more about this trial

A Study of TAK-341 in Treatment of Multiple System Atrophy

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