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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Universitaet Leipzig	Leipzig	Germany
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Kliniken Beelitz GmbH	Beelitz	Germany
Paracelsus-Kliniken Deutschland GmbH & Co. KGaA	Kassel	Germany
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona	Salerno	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Philipps-Universitaet Marburg	Marburg	Germany
Hospital Universitario De Cruces	Barakaldo	Spain
Irccs San Raffaele Roma S.r.l.	Rome	Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hopital Beaujon	Clichy	France
Hjohyvbo Udqavndnsxwvx Do Lj Pwerhhqv	Madrid	Spain
Amtzanxwqf Pdpeuuwd Hlfkicfg Dz Maioartpa	Marseille	France
Usuudmjegmqlkbltrnxwl Dfqnfjvfsxw Ari	Duesseldorf	Germany
Uyaoztxtjuswwrdqqewoa Mlexobdq Ady	Munster	Germany
Kdamzvjx dbk Utfgavhjapxg Mfbucjeb Ael	Munich	Germany
Hrugzejo Dm Lm Scgqe Chor I Skis Pap	Barcelona	Spain
Hqelmjug Vrvh dktvzhfr	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	03.03.2026
Germany	Recruiting	03.03.2026
Italy	Recruiting	03.03.2026
Spain	Recruiting	03.03.2026

Trial locations

Investigated drugs:

Emrusolmin

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.

Investigated diseases:

Multiple system atrophy

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 ID:

2025-521642-14-00

Protocol code:

TV56286-NDG-20041

Trial Phase:

Therapeutic exploratory (Phase II)

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

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