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

NCT05526391

CompletedPhase 2

Sponsor: Takeda

Conditions: Multiple System Atrophy

Interventions: Placebo, TAK-341

Countries: United States, Austria, Denmark, France, Germany, Italy, Japan, Portugal

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 overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (41)
  • Farmington Hills, Michigan, United States
  • Rochester, Minnesota, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Dallas, Texas, United States
  • Spokane, Washington, United States
  • Graz, Styria, Austria
  • København NV, Capital, Denmark
  • Aarhus N, Denmark
  • Marseille, Bouches-du-Rhone, France
  • München, Bavaria, Germany
  • Kassel, Hesse, Germany
  • Hanover, Lower Saxony, Germany
  • Bochum, North Rhine-Westphalia, Germany
  • Bonn, North Rhine-Westphalia, Germany
  • Münster, North Rhine-Westphalia, Germany
  • Dresden, Saxony, Germany
  • Leipzig, Saxony, Germany
  • Berlin, Germany
  • Rome, Lazio, Italy
  • Milan, Lombardy, Italy
  • Milan, Lombardy, Italy
  • Rozzano, Lombardy, Italy
  • Padova, Veneto, Italy
  • Salerno, Italy
  • Chuo-ku, Chiba, Japan
  • Sapporo, Hokkaido, Japan
  • Kyoto, Kyoto, Japan
  • Bunkyo-Ku, Tokyo, Japan
  • + 11 more on CT.gov