A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy (TOPAS-MSA)

November 4, 2026 updated by: Teva Branded Pharmaceutical Products R&D LLC

A Multi-centered, Double-blind, Randomized, Placebo-controlled, Parallel Group Phase 2 Study of TEV-56286 for the Treatment of Patients With Multiple System Atrophy (TOPAS-MSA)

The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA).

A secondary objective of the study is to evaluate specific efficacy parameters of TEV-56286.

Another secondary objective is to evaluate the safety and tolerability of TEV-56286.

The planned study period per participant is 56 weeks including a screening period (up to 4 weeks), a 48-week double-blind treatment period, and a follow-up visit (approximately 4 weeks after the end of the double-blind treatment period). The study duration will be approximately 27 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, Japan, and Serbia.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
349

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33400
        • Centre Hospitalier Universitaire (CHU) de Bordeaux
      • Caen, France, 14033
        • CHU de Caen
      • Marseille, France, 13385
        • CHU - Hospital de la Timone
      • Paris, France, 75651 Cedex 13
        • Chu De La Pitie-Salpetriere
      • Toulouse, France, 31059
        • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
  • Germany
      • Beelitz, Germany, 14547
        • Kliniken Beelitz GmbH - Neurologisches Fachkrankenhaus fuer Bewegungsstoerungen / Parkinson
      • Dresden, Germany, 01307
        • Universitatsklinikum Carl Gustav Carus an der Technischen Universitat Dresden
      • Düsseldorf, Germany, 40225
        • University Hospital Duesseldorf
      • Kassel, Germany, 34128
        • Paracelsus-Elena-Klinik
      • Leipzig, Germany, 04103
        • Universitaetsklinikum Leipzig
      • Marburg, Germany, 35033
        • Universitatsklinikum Giessen und Marburg GmbH
      • München, Germany, 81377
        • LMU - Klinikum der Universitaet Muenchen - Campus Grosshadern
      • Münster, Germany, 48149
        • Universitaetsklinikum Muenster
      • Ulm, Germany, 89081
        • University Of Ulm
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus (RHCC)
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Tel Aviv, Israel, 6423906
        • The Tel Aviv Sourasky Medical Center
  • Italy
      • Bologna, Italy, 40139
        • IRCCS Institute of Neurological Sciences of Bologna- Universita di Bologna
      • Catania, Italy, 95123
        • Clinica Neurologica-Aou Policlinico-Vittorio Emanuele-Po G. Rodolico
      • Milan, Italy, 20132
        • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario Sa
      • Padova, Italy, 35127
        • Azienda Ospedale Universita Padova
      • Roma, Italy, 00163
        • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana
      • Salerno, Italy, 84131
        • Universita degli Studi di Salerno - Facolta di Medicina e Chirurgia
  • Japan
      • Chiba, Japan, 260-8677
        • Chiba University Hospital
      • Fuchū, Japan, 183-0042
        • Tokyo Metropolitan Neurological Hospital
      • Gifu, Japan, 501-1112
        • Gifu University Hospital
      • Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital
      • Sagamihara, Japan, 252-0392
        • National Hospital Organization Sagamihara Hospital
      • Sanda-shi, Japan, 669-1592
        • Hyogo-Chuo National Hospital
      • Sendai, Japan, 982-8555
        • National Hospital Organization Sendai Nishitaga Hospital
  • Serbia
      • Belgrade, Serbia, 11000
        • Klinicki Centar Srbije (University Clinical Center of Serbia - KCS)
  • Spain
      • Barakaldo, Spain, 48903
        • Hospital Universitario Cruces
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Elche, Spain, 03203
        • Hospital General Universitario de Elche
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Pamplona, Spain, 31008
        • Universidad de Navarra - Clinica Universidad de Navarra (CUN)
      • Seville, Spain, 41015
        • Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
      • Valencia, Spain, 46026
        • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
  • United States
    • California
      • La Jolla, California, United States, 92037
        • University of California - San Diego
      • Los Angeles, California, United States, 90095
        • University California Los Angeles Medical Center (Ucla)
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Parkinson's Disease And Movement Disorder Center Of Boca Raton
      • Tampa, Florida, United States, 33613
        • University of South Florida Parkinson's Disease and Movement Disorders Center
    • Illinois
      • Chicago, Illinois, United States, 60612-3852
        • Rush University Medical Center-Allergy/ Immunology Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Detroit Clinical Research Center, PC
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10016
        • NYU Medical Center - Dysautonomia center
      • New York, New York, United States, 10032-3726
        • Columbia University Medical Center - The Neurological Institute of New York
    • North Carolina
      • Durham, North Carolina, United States, 27705-4410
        • Duke University School of Medicine - Duke Neurological Disorders Clinic - Morreene Road Location
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • University Of Pittsburgh
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center (VUMC)
    • Texas
      • Georgetown, Texas, United States, 78628
        • Texas Movement Disorder Specialists
    • Virginia
      • Alexandria, Virginia, United States, 22310
        • Integrated Neurology Services
    • Washington
      • Spokane, Washington, United States, 99202
        • Inland Northwest Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria

  • is medically and psychiatrically stable, as indicated by medical and psychiatric history, as well as physical and neurological examination

  • Females of child bearing potential (CBP) may be included only if they have a negative pregnancy test at the screening and baseline visits

  • Females of CBP whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods

  • Males who are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners who are of CBP must use, together with their female partners, highly effective birth control methods

    • Additional criteria apply; please contact the investigator for more information

Exclusion Criteria:

  • has 2 or more relatives with history of MSA, suggestive of an alternative diagnosis other than MSA

  • has participated in another clinical study involving administration of an IMP within 3 months or 5 half-lives (whichever is longer) of this IMP prior to screening

  • has a history of, or acknowledges, alcohol or other substance abuse in the 12 months before screening

  • is a female participant who is pregnant or breastfeeding, or plans to become pregnant during the study

  • has a known hypersensitivity to any components of the IMP

  • is of a vulnerable population (eg, people kept in detention or jail)

  • participant is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this study

    • Additional criteria apply; please contact the investigator for more information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TEV-56286

Orally administered capsules once daily
Drug: TEV-56286

TEV-56286 capsules administered orally

Other Names:
  • emrusolmin, anle138b
Placebo Comparator: Placebo

Orally administered capsules once daily
Drug: Placebo

Matching placebo administered orally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
For non-EU: Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (excluding item 11)
Time Frame: Baseline to Week 48

The UMSARS is a multidimensional, validated scale for semi-quantitative clinical assessments of MSA participants. Modified UMSARS part I includes all items with the exclusion of item 11. Item scoring is scaled 0-3 using a range of 0 (no impairment) to 3 (severe impairment).
Baseline to Week 48
For EU: Change From Baseline in the Total UMSARS Score Part I and Part II Combined
Time Frame: Baseline to Week 48

The UMSARS is comprised of 4 parts: part I, historical review of disease-related impairments, 12 items and part II, motor examination, 14 items. As UMSARS is a unified scale, each item in parts I and II achieves a single score using a range of 0 (no impairment) to 4 (severe impairment).
Baseline to Week 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAEs)
Time Frame: Up to Week 48
Up to Week 48
Number of Participants Who Withdraw From the Study Due to an Adverse Event
Time Frame: Up to Week 48
Up to Week 48
Number of Participants Who Withdraw From Treatment Due to an Adverse Event
Time Frame: Up to Week 48
Up to Week 48
Number of Participants With At Least One Potentially Clinically Significant Abnormal Vital Sign Value
Time Frame: Up to Week 48
Up to Week 48
Number of Participants With At Least One Potentially Clinically Significant Laboratory Test Value
Time Frame: Up to Week 48
Up to Week 48
Number of Participants with at Least One Potentially Clinically Significant Change in 12-lead Electrocardiogram (ECG) Findings
Time Frame: Up to Week 48
Up to Week 48
For non-EU: Change From Baseline in the Total UMSARS Score (Part I and Part II combined)
Time Frame: Baseline to Week 48
Baseline to Week 48
For EU: Change From Baseline in the Modified UMSARS part I score (excluding item 11, item scoring rescaled 0-3)
Time Frame: Baseline to Week 48
Baseline to Week 48
Change From Baseline in the UMSARS Part 1 Score
Time Frame: Baseline to Week 48
Baseline to Week 48
Change From Baseline in Lateral Ventricle Volume Measured by MRI
Time Frame: Baseline to Week 48
Baseline to Week 48
Change From Baseline in the Neurofilament Light Chain (NfL) Concentrations in Cerebrospinal Fluid (CSF)
Time Frame: Baseline to Week 48
Baseline to Week 48
Change From Baseline in the Pons volume measured by MRI
Time Frame: Baseline to Week 48
Baseline to Week 48
Change From Baseline in the Cerebellar volume measured by MRI
Time Frame: Baseline to Week 48
Baseline to Week 48
Change From Baseline in the UMSARS part II score
Time Frame: Baseline to Week 48
Baseline to Week 48
Change From Baseline in the UMSARS part IV score
Time Frame: Baseline to Week 48
Baseline to Week 48
Change From Baseline in the Two-minute walk test as part of gait assessment
Time Frame: Baseline to Week 48
Baseline to Week 48
Change From Baseline in the Clinical Global Impression - Severity scale (CGI-S)
Time Frame: Baseline to Week 48

The CGI-S scale permits a global evaluation of the participant's current severity of illness on a Likert type scale ranging from 1 to 7, where 1=normal/not at all ill, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill participants
Baseline to Week 48
Change From Baseline in the Patient Global Impression-Severity Scale (PGI-S)
Time Frame: Baseline to Week 48

The PGI-S scale permits an evaluation of the participant's MSA severity, according to the participant. The PGI-S scale rates the participant's MSA severity on a 5-point Likert type scale ranging from 0 (not severe) to 4 (very severe)
Baseline to Week 48
Change From Baseline in the Multiple System Atrophy - Quality of Life (MSA-QoL) Score
Time Frame: Baseline to Week 48

The 40-item MSA-QoL questionnaire is self-administered and each item is rated on a Likert type scale (0: No problem) to (4: Extreme problem). It is comprised of 3 subscales relevant to MSA: motor (14 items), non-motor (12 items), and emotional/social (14 items). The MSA-QoL total score is the sum of all the items and lower scores indicate better QoL.
Baseline to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Branded Pharmaceutical Products R&D LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Tev Medical Expert, Study Director, Teva Branded Pharmaceutical Products R&D LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TV56286-NDG-20039
  • 2023-505320-54-00 (Registry Identifier: CTIS (EU))
  • 2023 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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