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

About

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

40 Years

Maximum Age

N/A

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.

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