A Study of TAK-341 in Treatment of Multiple System Atrophy
Key facts
- Who runs it
- Takeda
- Where
- Cleveland, Dallas, Durham, Farmington Hills, New York, Rochester, and Spokane, United StatesSee the 7 sitesAlso in 9 other countries, 30 sites
- Trial code
- NCT05526391
- EU 2023-509876-40-00
- EudraCT 2022-000336-28
- JRCT2011220029
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 158 people enrolled
- Started
- 16 Nov 2022
- Ended
- 28 Jul 2025
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Placebo
- TAK-341
- Record updated
- 24 September 2026
Who can take part
- Age
- 40 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- 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:
- 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
- Presence of confounding diagnosis and/or conditions that could affect participant's safety during the study per investigator judgement
- Medical History:
- The participant has any contraindication to study procedures; Diagnostic Assessments:
Where in United States
Also in 9 other countries, 30 sites
- The Cleveland Clinic FoundationCleveland, United StatesNo longer taking part
- University of Texas Southwestern Medical CenterDallas, United StatesNo longer taking part
- Duke University School of MedicineDurham, United StatesNo longer taking part
- Quest Research Institute - Alcanza - HyperCoreFarmington Hills, United StatesNo longer taking part
- NYU Langone HealthNew York, United StatesNo longer taking part
- Mayo ClinicRochester, United StatesNo longer taking part
- Inland Northwest ResearchSpokane, United StatesNo longer taking part
About the trial
What the trial wants to find out
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).
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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 2 groups in the trial
- PlaceboPlacebo, for comparison
Participants received TAK-341 matching placebo intravenous (IV) infusions, once every 4 weeks (Q4W) for 52 weeks.
- TAK-341Treatment being tested
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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
- Record updated
- 24 September 2026