NCT05526391

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 138 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 treatment schedules-which will remain undisclosed to the participant, care provider and investigator during the study: * Early PK Cohort: TAK-341 * Early PK Cohort: Placebo * Main Cohort: TAK-341 * Main Cohort: Placebo 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.

Conditions

• Multiple System Atrophy

Interventions

Type	Name	Description
DRUG	TAK-341	TAK-341 IV infusion
DRUG	Placebo	TAK-341 placebo-matching IV infusion

Timeline

• Start date: 2022-11-09
• Primary completion: 2025-07-28
• Completion: 2025-07-28
• First posted: 2022-09-02
• Last updated: 2025-08-24

Locations

41 sites across 10 countries: United States, Austria, Denmark, France, Germany, Italy, Japan, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study