Phase 2
N=158
A Study of TAK-341 in Treatment of Multiple System Atrophy
Multiple System Atrophy
Bottom Line
View on ClinicalTrials.gov: NCT05526391 ↗Enrolled (actual)
158
Serious AEs
32.5%
Results posted
Jun 2026
Primary outcome: Primary: Change From Baseline in Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Total Score at Week 52 — 5.58; 5.54 score on a scale — p==0.961
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); TAK-341 (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jul 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Total Score at Week 52 |
5.58; 5.54 | =0.961 |
| SECONDARY Change From Baseline in 11-item UMSARS at Week 52 |
7.77; 6.58 | =0.241 |
| SECONDARY Change From Baseline in the UMSARS Total Score (UMSARS Part I + Part II) at Week 52 |
14.38; 12.57 | =0.322 |
| SECONDARY Change From Baseline in UMSARS Part I 11-Item Score at Week 52 |
6.37; 5.66 | =0.446 |
| SECONDARY Change From Baseline in UMSARS Part II at Week 52 |
6.96; 6.37 | =0.557 |
| SECONDARY Change From Baseline on Clinical Global Impression-Severity (CGI-S) Score |
0.41; 0.60; 0.83; 0.86 | =0.121 |
| SECONDARY Change From Baseline in Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT) Total Score |
2.24; 2.13; 4.66; 1.88 | =0.924 |
| SECONDARY Overall Survival (OS) at Week 52 |
0.955; 0.936 | =0.626 |
| SECONDARY Change From Baseline in Cerebrospinal Fluid (CSF) Free Alpha-Synuclein (αSYN) |
519.2; 427.2; -76.1; -185.0 | — |
| SECONDARY Maximum Observed Steady State Serum Concentration (Cmax) for TAK-341 |
715.5 | — |
| SECONDARY Time to Maximum Steady State Concentration (Tmax) for TAK-341 |
0.048 | — |
| SECONDARY Area Under the Serum Concentration Time Curve (AUCτ) at Steady State for TAK-341 |
4100.4 | — |
| SECONDARY CSF Concentration of TAK-341 |
0.2855; 665.3636; 616.5000 | — |
| SECONDARY Number of Participants With at Least One Adverse Event (AE) |
71; 73 | — |
| SECONDARY Number of Participants With Anti-Drug Antibodies |
1; 0 | — |
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.
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:
- 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:
- 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.
Data sourced from ClinicalTrials.gov (NCT05526391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.