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A Study of Emrusolmin Safety and Effectiveness in Adults with Multiple System Atrophy, a Brain and Nerve Disorder

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This study involves people with Multiple System Atrophy, a rare condition that affects the nervous system and causes problems with movement, balance, and body functions such as blood pressure control and bladder function. The study will test a medicine called Emrusolmin, which is also known by its code name TEV-56286. This medicine comes in capsule form and is taken by mouth. The medicine is being tested to see if it can help treat people with this condition.

The main purpose of the study is to learn about the long-term safety of Emrusolmin and how well people tolerate taking it over an extended period of time. The study will look at whether people experience any unwanted effects from the medicine and whether they are able to continue taking it without problems. This is called an open-label extension study, which means it follows on from an earlier study and all people taking part will know they are receiving the actual medicine rather than a placebo.

People who join this study must have already completed an earlier study with this medicine and must be able to swallow the capsules whole. During the study, people will take Emrusolmin capsules regularly and will attend visits where doctors will check their health and watch for any side effects. The medicine will be taken daily with a maximum dose of 300 milligrams per day. The study will continue for up to 96 weeks to collect information about how safe the medicine is when used over a longer time period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Transition from previous trial

    This trial is an extension of a previous study. Your participation begins after completing the treatment period and the week 48 visit of the earlier trial.

    Before starting, a dysphagia evaluation (swallowing test) will be performed during the baseline visit to ensure you can safely swallow the medication capsules.

    If you are a female of childbearing potential, a pregnancy test will be conducted at the baseline visit and must be negative to proceed.

  2. Step 2

    Consent and preparation

    You will need to provide consent to participate in this extension trial. This can be done by signature, spoken word, or gesture, depending on your physical abilities.

    If you are physically unable to provide written consent, a legally acceptable representative or an impartial witness may assist according to local regulations.

    If you have a caregiver who will be involved in the trial, their consent will also be obtained.

  3. Step 3

    Medication administration

    You will receive emrusolmin (also known as TEV-56286), which is provided in capsule form.

    The medication is taken orally (by mouth).

    You must swallow the capsules whole, without crushing or opening them.

    The medication will be taken as scheduled throughout the duration of the trial.

  4. Step 4

    Birth control requirements during treatment

    If you are a female of childbearing potential and your male partner has not had a vasectomy, you must use highly effective birth control methods throughout the trial and for 28 days after taking the last dose of medication.

    If you are a male who is fertile and your female partner is of childbearing potential, both of you must use highly effective birth control methods throughout the trial and for 28 days after you take the last dose of medication.

  5. Step 5

    Ongoing monitoring and visits

    Throughout the trial, you will attend scheduled visits to monitor the safety and tolerability of the medication.

    The medical team will track any adverse events (unwanted or harmful effects) that you may experience.

    You will need to remain compliant with all trial requirements, including taking the medication as scheduled and attending all visits.

  6. Step 6

    Trial completion

    The trial is designed to describe the long-term safety and effectiveness of emrusolmin in treating multiple system atrophy (a condition affecting movement and body functions).

    The trial is expected to continue until September 2029.

    Your participation will continue as long as you remain compliant with trial requirements and do not experience adverse events that require withdrawal from the trial.

Who can join the trial?

7 criteria

  • You must have completed the full treatment period and the week 48 visit of the previous double-blind trial (a type of study where neither you nor your doctor knew which treatment you were receiving) while following all the study requirements.
  • You must be able to swallow the study medicine capsules whole, which will be checked during your first visit for this extended study, and you must be willing to take the capsules as instructed throughout the entire study.
  • Your doctor must believe that you, and if needed your caregiver (a person who helps take care of you), can understand what this extended study involves and are able and willing to follow all the study requirements.
  • You must be able to provide your agreement to participate in the study by signing, speaking, or making a gesture. If you are physically unable to sign the consent form yourself, someone legally allowed to make decisions for you or an independent witness can help complete this process according to local rules. If you have a caregiver participating in the study, their agreement will also be needed.
  • If you are a woman who is able to become pregnant, you must have a negative pregnancy test (a test to check if you are pregnant) at the beginning of this extended study.
  • If you are a woman who is able to become pregnant and your male partner is able to father children, you must use very effective birth control methods (ways to prevent pregnancy) during the entire study and for 28 days after taking your last dose of the study medicine.
  • If you are a man who is able to father children and your female partner is able to become pregnant, you and your partner must use very effective birth control methods together during the entire study and for 28 days after you take your last dose of the study medicine.

Who cannot join the trial?

4 criteria

  • The source data does not contain specific exclusion criteria (reasons why patients cannot participate) for this clinical trial
  • Without detailed exclusion criteria information, it is not possible to list the specific conditions or situations that would prevent participation in this study
  • The trial is studying a medication called TEV 56286 for Multiple System Atrophy, which is a rare condition affecting the nervous system that controls automatic body functions
  • The study accepts both male and female adult participants
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Investigated drugs

TEV-56286 (also called Emrusolmin) is an investigational medication being studied for the treatment of Multiple System Atrophy (MSA). This is an oral medication, which means it is taken by mouth. The purpose of this trial is to evaluate how safe this medication is when taken over a long period of time and to see how well it works in adults with MSA. TEV-56286 is still being tested and is not yet approved for general use.

What is already known about the treatment

TEV-56286 (Emrusolmin) – This medication is taken by mouth and is currently being studied in Phase 2 clinical trials to evaluate its safety and effectiveness in treating patients with Multiple System Atrophy, a rare progressive neurological disorder that affects movement, blood pressure, and other body functions. The drug is being investigated as a potential treatment option, though it has not yet received full approval for widespread medical use. While the exact way it works at the cellular level is still being researched, it is designed to target the underlying disease processes in Multiple System Atrophy to potentially slow disease progression and improve patient outcomes.

Investigated diseases

Multiple System Atrophy – Multiple System Atrophy is a rare neurological disorder that affects the body's automatic functions and movement control. The disease occurs when certain areas of the brain and spinal cord deteriorate over time, particularly affecting nerve cells that control blood pressure, digestion, bladder function, and muscle coordination. People with this condition experience a combination of symptoms that may include difficulty with balance and coordination, stiffness, slow movement, and problems with automatic body functions like blood pressure regulation. The disease progresses gradually, with symptoms becoming more severe as more nerve cells are damaged. Early signs often include dizziness when standing up, clumsiness, and changes in speech or swallowing. As the condition advances, individuals may develop increasing difficulties with movement and daily activities due to the ongoing deterioration of affected brain regions.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521642-14-00Protocol codeTV56286-NDG-20041Estimated enrolment200 patientsSponsorTeva Branded Pharmaceutical Products R&D LLC

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