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Study on the Effects of TAK-341 for Patients with Multiple System Atrophy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a disease called Multiple System Atrophy (MSA). MSA is a rare condition that affects the nervous system, leading to problems with movement, balance, and the function of various body systems. The study is testing a treatment called TAK-341, which is a type of medication known as a human IgG1 lambda monoclonal antibody against alpha-synuclein. This medication is given through an infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective and safe TAK-341 is for people with MSA. Participants in the study will receive either the medication or a placebo, which is a substance with no active ingredients. The study will last for about 52 weeks, during which participants will have regular check-ups and assessments to monitor their health and the effects of the treatment. These assessments will include various tests and evaluations to see how the treatment is working and to ensure the safety of the participants.

Throughout the study, participants will be closely monitored by healthcare professionals. The study aims to provide valuable information about the potential benefits and safety of TAK-341 for treating Multiple System Atrophy. This research could help improve the understanding and management of this challenging condition in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be informed about the procedures, potential benefits, side effects, and risks involved. This information is provided through an informed consent form, which must be signed to confirm understanding and agreement to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes evaluating cognitive function, body mass index, and the severity of symptoms related to multiple system atrophy (MSA).

  3. Step 3

    Treatment administration

    The treatment involves the administration of a human igg1 lambda monoclonal antibody against alfa-synuclein or a placebo. This is given as a solution for infusion through intravenous use.

    The treatment is administered regularly over a period of 52 weeks. The exact schedule and dosage will be determined by the study protocol.

  4. Step 4

    Ongoing assessments

    Throughout the study, regular assessments will be conducted to monitor the participant's health and the effects of the treatment. These assessments include clinical evaluations, laboratory tests, and imaging studies.

  5. Step 5

    Final evaluation

    At the end of the 52-week period, a final evaluation will be conducted to assess the overall impact of the treatment. This includes measuring changes in symptoms and any side effects experienced during the study.

Who can join the trial?

12 criteria

  • The person or their legal representative must sign a form showing they understand the study, its experimental nature, possible benefits, risks, and discomforts.
  • The person must have a **MoCA** score of 18 or higher. **MoCA** stands for Montreal Cognitive Assessment, a test to check thinking abilities.
  • Men who can have children and are sexually active must agree to use a condom during the study and for a certain period after the last dose. They should also not donate sperm during this time.
  • Women can join if they are not pregnant or breastfeeding and agree to use effective birth control during the study and for a certain period after the last dose.
  • The person must be at least 40 years old and not staying in a hospital.
  • The person should be able to attend all study appointments and complete all tests, including brain scans and a procedure called a lumbar puncture.
  • The person must have a **body mass index (BMI)** between 18 and 35. **BMI** is a measure of body fat based on height and weight.
  • The person must have a diagnosis of possible or probable **Multiple System Atrophy (MSA)**, a condition affecting the nervous system.
  • The first symptoms of **MSA** must have started within the last 4 years.
  • The person should have a life expectancy of at least 3 years, according to the study doctor's judgment.
  • The person must have a specific score on a test called **UMSARS Part I**, which measures symptoms of **MSA**. This includes scores on swallowing, walking, and falling items.
  • The person must have a specific score on **UMSARS Part IV**, which measures disability related to **MSA**.

Who cannot join the trial?

4 criteria

  • Individuals who do not have a diagnosis of Multiple System Atrophy cannot participate. This is a condition that affects the nervous system.
  • Participants must be within a certain age range, typically adults and older adults.
  • Both males and females are eligible, but certain health conditions may exclude participation.
  • People who are considered part of a vulnerable population may not be eligible. This term refers to groups who might be at a higher risk of harm or exploitation.
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Investigated drugs

TAK-341 is an investigational medication being studied for its potential to treat Multiple System Atrophy, a rare neurological disorder. The trial aims to assess how effective, safe, and tolerable this medication is when given intravenously. Researchers are also studying how the body processes and responds to TAK-341 over time.

What is already known about the treatment

TAK-341 – TAK-341 is administered intravenously and is currently being studied in a Phase 2 clinical trial for its potential use in treating Multiple System Atrophy, a rare neurodegenerative disorder. The medication is under investigation to determine its efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics. TAK-341 is believed to work by targeting specific pathways involved in the progression of the disease, although the exact molecular mechanism is still being explored. It is classified as an investigational drug, and its effects are being compared to a placebo to assess its therapeutic benefits.

Investigated diseases

Multiple System Atrophy – Multiple System Atrophy is a rare neurological disorder that affects the body's involuntary functions, including blood pressure, breathing, bladder function, and motor control. It is characterized by a combination of symptoms similar to Parkinson's disease, such as slow movement, muscle rigidity, and poor balance. As the disease progresses, individuals may experience increasing difficulty with movement and coordination, as well as problems with autonomic functions like blood pressure regulation and bladder control. The condition is caused by the degeneration of nerve cells in specific areas of the brain, leading to a decline in motor and autonomic functions. Symptoms typically begin in adulthood and worsen over time, affecting daily activities and quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509876-40-00Protocol codeTAK-341-2001Estimated enrolment159 patientsSponsorTakeda Development Center Americas Inc.

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