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Study of Emrusolmin for Treating Adults 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 condition known as Multiple System Atrophy (MSA), a rare neurological disorder that affects the body's involuntary functions, such as blood pressure, breathing, and motor control. The study will evaluate a new treatment called Emrusolmin, which is also known by its code name TEV-56286. This medication is taken orally in the form of a capsule. The trial will compare the effects of Emrusolmin with a placebo to understand its effectiveness in treating MSA.

The purpose of the study is to assess how well Emrusolmin works in improving the symptoms of MSA. Participants in the study will be randomly assigned to receive either Emrusolmin or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This approach helps ensure that the results are unbiased. The study will last for a period of 48 weeks, during which participants will be monitored regularly to track any changes in their condition and to ensure their safety.

Throughout the study, various assessments will be conducted to evaluate the impact of the treatment on the participants' symptoms and overall quality of life. These assessments will include standardized tests and questionnaires that measure the severity of MSA symptoms and the participants' well-being. The study aims to provide valuable information about the potential benefits of Emrusolmin for individuals living with Multiple System Atrophy.

The research process

The trial runs in 7 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, eligibility is confirmed based on specific criteria. Participants must be at least 30 years old and diagnosed with multiple system atrophy (MSA) as per the Gilman criteria. The ability to walk at least 10 meters without assistance is required, although the use of devices like a walker or cane is allowed.

  2. Step 2

    Randomization and treatment assignment

    Participants are randomly assigned to receive either the investigational medication emrusolmin or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives which treatment.

  3. Step 3

    Medication administration

    The medication, emrusolmin, is administered orally in the form of a capsule. The exact dosage and frequency are determined by the study protocol and are followed throughout the trial duration.

  4. Step 4

    Treatment duration

    The treatment period lasts for 48 weeks. During this time, participants continue to take the assigned medication as directed.

  5. Step 5

    Evaluation of treatment efficacy

    The primary goal is to assess the effectiveness of emrusolmin compared to the placebo. This is measured by changes in the modified Unified Multiple System Atrophy Rating Scale (UMSARS) from the start of the study to week 48.

  6. Step 6

    Secondary evaluations

    Secondary assessments include the total UMSARS score, Clinical Global Impression of Severity (CGI-S), and MSA Quality of Life (MSA-QoL). Safety is monitored by tracking adverse events, withdrawals due to adverse events, and significant changes in vital signs, laboratory tests, and ECG measurements.

  7. Step 7

    Completion of the study

    The study is expected to conclude by September 20, 2026. Participants will have completed all required assessments and treatments by this time.

Who can join the trial?

3 criteria

  • Must be a male or female who is **30 years old or older** at the time of screening.
  • Must have a diagnosis of **Multiple System Atrophy (MSA)** that is considered "clinically possible" or "clinically probable" according to the **Gilman criteria**. The Gilman criteria are guidelines used by doctors to help diagnose MSA.
  • Must be able to walk at least **10 meters** (about 33 feet) without needing help from another person during the screening. However, using devices like a walker or cane is allowed.

Who cannot join the trial?

4 criteria

  • Patients who are not adults cannot participate. This means only individuals who are 18 years or older are eligible.
  • Patients who do not have a confirmed diagnosis of Multiple System Atrophy (MSA) cannot participate. MSA is a rare condition that affects the nervous system.
  • Patients who are unable to take medication by mouth cannot participate. The study involves taking a medication orally, which means swallowing a pill or liquid.
  • Patients who are part of a vulnerable population may not be eligible. Vulnerable populations can include groups like pregnant women or people with certain disabilities.
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Investigated drugs

TEV-56286 is an investigational medication being studied for its potential to treat patients with Multiple System Atrophy (MSA). This medication is taken orally and is being evaluated to see how effective it is in improving the symptoms of MSA, a rare neurological disorder that affects movement, balance, and autonomic functions.

What is already known about the treatment

TEV-56286 – This medication is administered orally and is currently being studied in a Phase 2 clinical trial for its effectiveness in treating Multiple System Atrophy (MSA). As of now, it is not yet approved for general medical use and is primarily discussed in the context of ongoing research. The main therapeutic indication for TEV-56286 is to alleviate symptoms associated with MSA, a rare neurodegenerative disorder. Its mechanism of action involves modulating specific pathways in the brain to potentially improve neurological function. TEV-56286 is classified pharmacologically as a neuroprotective agent.

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 difficulties with coordination and speech, as well as problems with autonomic functions like blood pressure regulation. The condition typically worsens over time, leading to increased disability. The exact cause of Multiple System Atrophy is unknown, and it is considered a sporadic disease, meaning it usually occurs randomly rather than being inherited.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505320-54-00Protocol codeTV56286-NDG-20039Estimated enrolment350 patientsSponsorTeva Branded Pharmaceutical Products R&D LLC

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