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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000336-28 | EudraCT Number | ||
| jRCT2011220029 | Registry Identifier | jRCT | |
| 2023-509876-40-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
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 158 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 two treatment groups-which will remain undisclosed to the participant, care provider and investigator during the study:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received TAK-341 matching placebo intravenous (IV) infusions, once every 4 weeks (Q4W) for 52 weeks. |
|
| TAK-341 | Experimental | Participants received TAK-341, IV Q4W for 52 weeks. An early set of participants initially received 2400 milligrams (mg) to determine pharmacokinetic (PK) parameters. Following the early participants, a dose of 2000 mg was given until the data from the PK participants became available. All participants then received 2400 mg until the end of treatment at 52 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | TAK-341-matching placebo IV infusion |
| |
| TAK-341 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Total Score at Week 52 | UMSARS Part I (historical review) is a 12-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 autonomic dysfunction. In this study, the UMSARS was modified to exclude the sexual function item. Thus, total 11 items were assessed. Each item was initially scored on a scale from 0 (normal) to 4 (severe); ratings of normal (0) and mild (1) were then combined and recorded as 0, making minimum score 0 and maximum score 3. The investigator rated the average functional situation for the past 2 weeks according to findings from the participant and caregiver interview and indicated the score that best fit with the participant's status. The total score is a sum of scores from all domains and range from 0 to 33. Higher scores indicate worse impairment. | Baseline, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 11-item UMSARS at Week 52 | The 11- item UMSARS includes 11 items from Part I and II to assess 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 was scored on a scale from 0 (normal) to 4 (severe); total score ranges from 0 to 44, higher scores indicated worse impairment. |
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Inclusion criteria:
Diagnostic:
Exclusion criteria:
Medical History:
1. The participant has any contraindication to study procedures.
Diagnostic Assessments:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quest Research Institute - Alcanza - HyperCore | Farmington Hills | Michigan | 48025 | United States | ||
| Mayo Clinic |
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| Label | URL |
|---|---|
| To obtain more information about this study, click this link. | View source |
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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.
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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.
A total of 158 participants with possible or probable multiple system atrophy (MSA), received multiple intravenous (IV) infusions of either TAK-341 or placebo, every 4 weeks (Q4W) over 52 weeks. The study comprised of a screening period of 6 weeks, a 52-week treatment period, and a follow-up visit approximately 90 days after the final infusion.
Participants participated across investigative sites in the United States, Austria, Denmark, France, Germany, Italy, Japan, Portugal, Spain, and the United Kingdom between 16 November 2022 and 28 July 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received TAK-341-matching placebo IV infusions, Q4W for 52 weeks. |
| FG001 | TAK-341 | Participants received TAK-341, IV infusions, Q4W for 52 weeks. A set of participants initially received 2400 milligrams (mg) to determine pharmacokinetic (PK) parameters. Following the early participants, a dose of 2000 mg was given until the initial PK data became available. All participants then received 2400 mg until the end of treatment at 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 29, 2023 | Apr 8, 2026 |
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| Drug |
TAK-341 IV infusion |
|
|
| Baseline, Week 52 |
| Change From Baseline in the UMSARS Total Score (UMSARS Part I + Part II) 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 (for example 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. The worst affected limb was assessed, and each item was scored from 0 (normal) to 4 (severe). UMSARS Part I and Part II total score is the sum of UMSARS Part I and Part II and ranges from 0 to 104. A higher score indicates worse impairment. | Baseline, Week 52 |
| Change From Baseline in UMSARS Part I 11-Item Score at Week 52 | UMSARS Part I (historical review) is a 12-item scale that was adapted from the UPDRS. In this study, the UMSARS was modified to exclude the sexual function item. The UMSARS is used to assess activities related to motor disability and autonomic dysfunction. Each item was scored on a scale from 0 (normal) to 4 (severe). UMSARS Part I 11-item total score is the total score of UMSARS Part I, excluding the sexual function item, and without collapse of ratings of scale items. The UMSARS Part I 11-item total score ranges from 0 to 44, and higher scores indicate worse impairment. | Baseline, Week 52 |
| Change From Baseline in UMSARS Part II at Week 52 | UMSARS Part II (motor examination): 14-item scale used to measure the functional impairment (e.g., 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. the worst affected limb was assessed, and each item was scored from 0 (normal) to 4 (severe). The UMSARS Part II total score ranges from 0 to 56, and higher scores indicate worse impairment. | Baseline, Week 52 |
| Change From Baseline on 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 rates the current severity of the participant's illness on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (most extremely ill). The rating was based on observed and reported symptoms, behaviour, and function and reflected the severity level at the time of the assessment. A higher score indicates worse impairment. | Baseline, Week 24 and Week 52 |
| Change From Baseline in Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT) Total Score | The SCOPA-AUT is a participant-reported outcome that assesses autonomic function. Autonomic function is a critical symptom domain for MSA. The scale was completed by participants and consisted 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 ranged from 0 (never experiencing the symptom) to 3 (often experiencing the symptom). The total composite score including all domains was reported. The score range was 0 (no symptoms) to 69 (highest burden of symptoms). A higher score indicates worse impairment. | Baseline, Week 24 and Week 52 |
| Overall Survival (OS) at Week 52 | OS was estimated with Kaplan-Meier survival estimates, along with 95% confidence interval. A cox proportional hazards model was fitted to model the survival probability with treatment as the predictor. The participants with missing value were censored. The probabilities of survival at Week 52 for participants were estimated and reported. | At Week 52 |
| Change From Baseline in Cerebrospinal Fluid (CSF) Free Alpha-Synuclein (αSYN) | α-Synucleinopathies are diseases characterized by abnormal accumulation of aggregated αSYN. In participants with MSA, αSYN is seen to accumulate primarily in oligodendrocytes, forming glial cytoplasmic inclusions. A negative change from Baseline indicates an improvement. | Baseline, Week 52 |
| Maximum Observed Steady State Serum Concentration (Cmax) for TAK-341 | Cmax is the maximum observed serum concentration for TAK-341. | On Day 57- immediately before end of infusion (EOI) (60 minutes), 6 hours and 24 hours. |
| Time to Maximum Steady State Concentration (Tmax) for TAK-341 | Tmax is the time of first occurrence of maximum observed concentration for TAK-341. | On Day 57- immediately before EOI (60 minutes), 6 hours and 24 hours. |
| Area Under the Serum Concentration Time Curve (AUCτ) at Steady State for TAK-341 | AUCτ is the area under the serum concentration-time curve during a dosing interval. | On Day 57- immediately before EOI (60 minutes), 6 hours and 24 hours. |
| CSF Concentration of TAK-341 | Lumbar puncture was performed for CSF on Day 1, Day 85 and Day 365, predose. | On Day 1, Day 85 and Day 365 |
| Number of Participants With at Least One Adverse Event (AE) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event that occurs after administration of the first dose of study treatment and up through 90 days after the last dose of study treatment. | Up to Week 61 |
| Number of Participants With Anti-Drug Antibodies | Up to Week 61 |
| Rochester |
| Minnesota |
| 55905-0001 |
| United States |
| NYU Langone Health | New York | New York | 10016-6402 | United States |
| Duke University School of Medicine | Durham | North Carolina | 27705-4410 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-7208 | United States |
| Inland Northwest Research | Spokane | Washington | 99202-1342 | United States |
| Medizinische Universitat Graz | Graz | Styria | 8036 | Austria |
| Bispebjerg Hospital | København NV | Capital | 2400 | Denmark |
| Aarhus Universitetshospital | Aarhus N | 8200 | Denmark |
| Hopitaux de La Timone | Marseille | Bouches-du-Rhone | 13385 | France |
| Klinikum Groshadern, LMU | München | Bavaria | 81377 | Germany |
| Paracelsus-Elena-Klinik Kassel | Kassel | Hesse | 34128 | Germany |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | 30625 | Germany |
| Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB) - St. Josef-Hospital | Bochum | North Rhine-Westphalia | 44791 | Germany |
| Deutsches Zentrum fur Neurodegenerative Erkrankung | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Universitatsklinikum Munster | Münster | North Rhine-Westphalia | 48149 | Germany |
| Universitatsklinikum Carl Gustav Carus an der TU Dresden | Dresden | Saxony | 01307 | Germany |
| Universitatsklinikum Leipzig | Leipzig | Saxony | 04103 | Germany |
| Charite - Universitatsmedizin Berlin | Berlin | 10117 | Germany |
| IRCCS San Raffaele Roma | Rome | Lazio | 00163 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan | Lombardy | 20122 | Italy |
| Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta | Milan | Lombardy | 20133 | Italy |
| Istituto Clinico Humanitas | Rozzano | Lombardy | 20089 | Italy |
| Azienda Ospedale Universita Padova | Padova | Veneto | 35126 | Italy |
| Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi dAragona | Salerno | 84131 | Italy |
| Chiba University Hospital | Chuo-ku | Chiba | 260-8677 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8638 | Japan |
| Kyoto University Hospital | Kyoto | Kyoto | 606-8507 | Japan |
| The University of Tokyo Hospital | Bunkyo-Ku | Tokyo | 113-0033 | Japan |
| Medical Hospital of Tokyo Medical and Dental University | Bunkyo-Ku | Tokyo | 113-8519 | Japan |
| National Center of Neurology and Psychiatry | Kodaira-Shi | Tokyo | 187-8551 | Japan |
| Campus Neurologico Senior | Loures | Lisbon District | 2674-514 | Portugal |
| Hospital Pedro Hispano | Senhora da Hora | Porto District | 4464-513 | Portugal |
| Hospital Universitario Cruces | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital de La Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitario de La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Southampton General Hospital | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Full Analysis Set | The full analysis set included all randomized participants. |
|
| Safety Analysis Set | The safety analysis set included all randomized participants who received at least 1 dose of the study drug. |
|
| COMPLETED |
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| NOT COMPLETED |
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|
The full analysis set included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received TAK-341-matching placebo IV infusions, Q4W for 52 weeks. |
| BG001 | TAK-341 | Participants received TAK-341, IV infusions, Q4W for 52 weeks. A set of participants initially received 2400 mg to determine PK parameters. Following the early participants, a dose of 2000 mg was given until the initial PK data became available. All participants then received 2400 mg until the end of treatment at 52 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Total Score at Week 52 | UMSARS Part I (historical review) is a 12-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 autonomic dysfunction. In this study, the UMSARS was modified to exclude the sexual function item. Thus, total 11 items were assessed. Each item was initially scored on a scale from 0 (normal) to 4 (severe); ratings of normal (0) and mild (1) were then combined and recorded as 0, making minimum score 0 and maximum score 3. The investigator rated the average functional situation for the past 2 weeks according to findings from the participant and caregiver interview and indicated the score that best fit with the participant's status. The total score is a sum of scores from all domains and range from 0 to 33. Higher scores indicate worse impairment. | The full analysis set included all randomized participants. Here, "overall number of participants analyzed" signifies the number of participants with data available for analysis of this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in 11-item UMSARS at Week 52 | The 11- item UMSARS includes 11 items from Part I and II to assess 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 was scored on a scale from 0 (normal) to 4 (severe); total score ranges from 0 to 44, higher scores indicated worse impairment. | The full analysis set included all randomized participants. Here, "overall number of participants analyzed" signifies the number of participants with data available for analysis of this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in the UMSARS Total Score (UMSARS Part I + Part II) 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 (for example 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. The worst affected limb was assessed, and each item was scored from 0 (normal) to 4 (severe). UMSARS Part I and Part II total score is the sum of UMSARS Part I and Part II and ranges from 0 to 104. A higher score indicates worse impairment. | The full analysis set included all randomized participants. Here, "overall number of participants analyzed" signifies the number of participants with data available for analysis of this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in UMSARS Part I 11-Item Score at Week 52 | UMSARS Part I (historical review) is a 12-item scale that was adapted from the UPDRS. In this study, the UMSARS was modified to exclude the sexual function item. The UMSARS is used to assess activities related to motor disability and autonomic dysfunction. Each item was scored on a scale from 0 (normal) to 4 (severe). UMSARS Part I 11-item total score is the total score of UMSARS Part I, excluding the sexual function item, and without collapse of ratings of scale items. The UMSARS Part I 11-item total score ranges from 0 to 44, and higher scores indicate worse impairment. | The full analysis set included all randomized participants. Here, "overall number of participants analyzed" signifies the number of participants with data available for analysis of this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in UMSARS Part II at Week 52 | UMSARS Part II (motor examination): 14-item scale used to measure the functional impairment (e.g., 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. the worst affected limb was assessed, and each item was scored from 0 (normal) to 4 (severe). The UMSARS Part II total score ranges from 0 to 56, and higher scores indicate worse impairment. | The full analysis set included all randomized participants. Here, "overall number of participants analyzed" signifies the number of participants with data available for analysis of this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline on 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 rates the current severity of the participant's illness on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (most extremely ill). The rating was based on observed and reported symptoms, behaviour, and function and reflected the severity level at the time of the assessment. A higher score indicates worse impairment. | The full analysis set included all randomized participants. Here, "overall number of participants analyzed" signifies the number of participants with data available for analysis of this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24 and Week 52 |
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| Secondary | Change From Baseline in Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT) Total Score | The SCOPA-AUT is a participant-reported outcome that assesses autonomic function. Autonomic function is a critical symptom domain for MSA. The scale was completed by participants and consisted 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 ranged from 0 (never experiencing the symptom) to 3 (often experiencing the symptom). The total composite score including all domains was reported. The score range was 0 (no symptoms) to 69 (highest burden of symptoms). A higher score indicates worse impairment. | The full analysis set included all randomized participants. Here, "overall number of participants analyzed" signifies the number of participants with data available for analysis of this outcome measure. Number analyzed are the participants with data available for analysis at specified time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24 and Week 52 |
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| Secondary | Overall Survival (OS) at Week 52 | OS was estimated with Kaplan-Meier survival estimates, along with 95% confidence interval. A cox proportional hazards model was fitted to model the survival probability with treatment as the predictor. The participants with missing value were censored. The probabilities of survival at Week 52 for participants were estimated and reported. | The full analysis set included all randomized participants. | Posted | Number | 95% Confidence Interval | unitless | At Week 52 |
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| Secondary | Change From Baseline in Cerebrospinal Fluid (CSF) Free Alpha-Synuclein (αSYN) | α-Synucleinopathies are diseases characterized by abnormal accumulation of aggregated αSYN. In participants with MSA, αSYN is seen to accumulate primarily in oligodendrocytes, forming glial cytoplasmic inclusions. A negative change from Baseline indicates an improvement. | The pharmacodynamic analysis set included randomized participants who received at least 1 dose of study drug, and who had at least 1 measurable plasma or CSF (as applicable) concentration of αSYN. Here, "overall number of participants analyzed" signifies the number of participants with data available for analysis of this outcome measure. Number analyzed are the participants with data available for analysis at given timepoint. | Posted | Mean | Standard Deviation | picograms per milliliter (pg/mL) | Baseline, Week 52 |
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| Secondary | Maximum Observed Steady State Serum Concentration (Cmax) for TAK-341 | Cmax is the maximum observed serum concentration for TAK-341. | The Pharmacokinetic analysis set included participants who were randomized and received at least 1 dose of study drug and who had at least 1 measurable serum concentration of TAK-341. Here, "overall number of participants analyzed" signifies the number of participants with data available for analysis of this outcome measure. | Posted | Mean | Standard Deviation | micrograms per milliliter (ug/mL) | On Day 57- immediately before end of infusion (EOI) (60 minutes), 6 hours and 24 hours. |
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| Secondary | Time to Maximum Steady State Concentration (Tmax) for TAK-341 | Tmax is the time of first occurrence of maximum observed concentration for TAK-341. | The Pharmacokinetic analysis set included participants who were randomized and received at least 1 dose of study drug and who had at least 1 measurable serum concentration of TAK-341. Here, "overall number of participants analyzed" signifies the number of participants with data available for analysis of this outcome measure. | Posted | Median | Full Range | days | On Day 57- immediately before EOI (60 minutes), 6 hours and 24 hours. |
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| Secondary | Area Under the Serum Concentration Time Curve (AUCτ) at Steady State for TAK-341 | AUCτ is the area under the serum concentration-time curve during a dosing interval. | The Pharmacokinetic analysis set included participants who were randomized and received at least 1 dose of study drug and who had at least 1 measurable serum concentration of TAK-341. Here, "overall number of participants analyzed" signifies the number of participants with data available for analysis of this outcome measure. | Posted | Mean | Standard Deviation | day*ug/mL | On Day 57- immediately before EOI (60 minutes), 6 hours and 24 hours. |
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| Secondary | CSF Concentration of TAK-341 | Lumbar puncture was performed for CSF on Day 1, Day 85 and Day 365, predose. | The pharmacodynamic analysis set included participants who were randomized and received at least 1 dose of study drug and who had at least 1 measurable plasma or CSF (as applicable) concentration of αSYN. Here, "overall number of participants analyzed" signifies the number of samples with data available for analysis of this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | On Day 1, Day 85 and Day 365 |
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| Secondary | Number of Participants With at Least One Adverse Event (AE) | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event that occurs after administration of the first dose of study treatment and up through 90 days after the last dose of study treatment. | The safety analysis set included all randomized participants who received at least 1 dose of the study drug. Here, "overall number of participants analyzed" signifies the number of participants with data available for analysis of this outcome measure. | Posted | Count of Participants | Participants | Up to Week 61 |
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| Secondary | Number of Participants With Anti-Drug Antibodies | The safety analysis set included all randomized participants who received at least 1 dose of the study drug. Here, "overall number of participants analyzed" signifies the number of participants with data available for analysis of this outcome measure. | Posted | Count of Participants | Participants | Up to Week 61 |
|
|
Adverse events: Up to Week 61; All-Cause Mortality: Up to Week 76.8
All-Cause Mortality was assessed for the full analysis set which included all randomized participants. Adverse Events were assessed for the safety analysis set which included all randomized participants who received at least 1 dose of the study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received TAK-341-matching placebo IV infusions, Q4W for 52 weeks. | 4 | 74 | 22 | 74 | 60 | 74 |
| EG001 | TAK-341 | Participants received TAK-341, IV infusions, Q4W for 52 weeks. A set of participants initially received 2400 mg to determine PK parameters. Following the early participants, a dose of 2000 mg was given until the initial PK data became available. All participants then received 2400 mg until the end of treatment at 52 weeks. | 6 | 84 | 29 | 83 | 64 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Bacterial prostatitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Brain injury | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Euthanasia | Surgical and medical procedures | MedDRA 28.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Near drowning | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Pleural injury | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 5, 2025 | Apr 8, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D019578 | Multiple System Atrophy |
| ID | Term |
|---|---|
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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