ClinicalTrials.gg
Active, not recruitingNCT06568237TOPAS-MSAUpdated Nov 5, 2026

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

A Phase 2 interventional study of TEV-56286 and Placebo in Multiple System Atrophy, sponsored by Teva Branded Pharmaceutical Products R&D LLC. Active, not recruiting at 61 sites in 8 countries. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Teva Branded Pharmaceutical Products R&D LLC (part of Teva Pharmaceutical Industries, Ltd.) · Phase 2, Interventional, and Treatment

Updated Nov 5, 2026Now Active, not recruitingEnrollment updated+2 moreGo to Updates ↓

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Phase
Phase 2
Study type
Interventional
Enrollment
349
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 90 studies in Multiple System Atrophy with a site in United States — 21 open to participants now, 32 under way, 1 of them phase 3. Multiple System Atrophy · United States.

Enrollment
7th of 57
349 · median 35
Started
2024
with 3 others
Phase 2
17 of 90
2 open now
Primary completion
2027-09
later than 23 of 31 live
Registered
79th of 90
by date

Among the 90 studies in Multiple System Atrophy with a site in United States, this one is the 7th largest by enrollment of the 57 interventional ones that give a count, is one of 4 that started in 2024, is one of 17 in phase 2, reaches primary completion later than 23 of the 31 other live ones, and was the 79th registered.

Multiple System Atrophy

207 studies on the registry are indexed under Multiple System Atrophy; 73 are open to participants now.

Browse Multiple System Atrophy studies →

Open to participants now

21 of the 90 studies in Multiple System Atrophy with a site in United States are open now. Recruiting first, the newest first:

16 more — sign in →

All 21 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 57 Multiple System Atrophy studies recruiting now, 24 (42%) set no upper age limit and 11 (19%) stop at 75 or younger; 7 take children under 18; 18 take healthy volunteers.

This study: 30 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 90 studies in Multiple System Atrophy with a site in United States, or all of them as a file.
02

Study summary

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.

Read the detailed description

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

03

Conditions studied

  • Multiple System Atrophy

Keywords

  • Multiple System Atrophy (MSA)
04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
349 participants (actual)

Study arms

  • Experimental
    TEV-56286

    Orally administered capsules once daily

    Drug: TEV-56286

  • Placebo comparator
    Placebo

    Orally administered capsules once daily

    Drug: Placebo

Interventions

  • DrugTEV-56286

    TEV-56286 capsules administered orally

    Also known as: emrusolmin, anle138b

  • DrugPlacebo

    Matching placebo administered orally

06

What researchers measure

Primary outcomes

  1. For non-EU: Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (excluding item 11)

    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).

    Time frame: Baseline to Week 48

  2. For EU: Change From Baseline in the Total UMSARS Score Part I and Part II Combined

    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).

    Time frame: Baseline to Week 48

Secondary outcomes

  1. For non-EU: Change From Baseline in the Total UMSARS Score (Part I and Part II combined)

    Time frame: Baseline to Week 48

  2. 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

  3. Change From Baseline in the UMSARS Part 1 Score

    Time frame: Baseline to Week 48

  4. Change From Baseline in Lateral Ventricle Volume Measured by MRI

    Time frame: Baseline to Week 48

  5. Change From Baseline in the Clinical Global Impression - Severity scale (CGI-S)

    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

    Time frame: Baseline to Week 48

  6. Change From Baseline in the Neurofilament Light Chain (NfL) Concentrations in Cerebrospinal Fluid (CSF)

    Time frame: Baseline to Week 48

  7. Change From Baseline in the Patient Global Impression-Severity Scale (PGI-S)

    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)

    Time frame: Baseline to Week 48

  8. Change From Baseline in the Pons volume measured by MRI

    Time frame: Baseline to Week 48

  9. Change From Baseline in the Cerebellar volume measured by MRI

    Time frame: Baseline to Week 48

  10. Change From Baseline in the UMSARS part II score

    Time frame: Baseline to Week 48

  11. Change From Baseline in the UMSARS part IV score

    Time frame: Baseline to Week 48

  12. Change From Baseline in the Two-minute walk test as part of gait assessment

    Time frame: Baseline to Week 48

  13. Change From Baseline in the Multiple System Atrophy - Quality of Life (MSA-QoL) Score

    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.

    Time frame: Baseline to Week 48

  14. Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAEs)

    Time frame: Up to Week 48

  15. Number of Participants Who Withdraw From the Study Due to an Adverse Event

    Time frame: Up to Week 48

  16. Number of Participants Who Withdraw From Treatment Due to an Adverse Event

    Time frame: Up to Week 48

  17. Number of Participants With At Least One Potentially Clinically Significant Abnormal Vital Sign Value

    Time frame: Up to Week 48

  18. Number of Participants With At Least One Potentially Clinically Significant Laboratory Test Value

    Time frame: Up to Week 48

  19. Number of Participants with at Least One Potentially Clinically Significant Change in 12-lead Electrocardiogram (ECG) Findings

    Time frame: Up to Week 48

07

Study locations

61 sites
08

References and documents

Individual participant data

Plan to share: Yes — 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.

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Sep 2027, 35 months after the start.

Of 19 phase 2 interventional studies under Multiple System Atrophy, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 32. This study's planned 35 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2024
First posted
Aug 23, 2024
StartActual
Oct 2, 2024
Primary completionEst.
Sep 15, 2027
CompletionEst.
Sep 15, 2027
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 7, 2026
Sites
61 sites added, 61 sites removed
Show 61 added (19 United States, 11 Spain, 9 Germany, 7 Japan, 6 Italy, 5 France, 3 Israel, 1 Serbia)
  • University of California - San Diego · La Jolla, United States
  • University California Los Angeles Medical Center (Ucla) · Los Angeles, United States
  • MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH) · Washington D.C., United States
  • Parkinson's Disease And Movement Disorder Center Of Boca Raton · Boca Raton, United States
  • University of South Florida Parkinson's Disease and Movement Disorders Center · Tampa, United States
  • Rush University Medical Center-Allergy/ Immunology Center · Chicago, United States
  • University of Kansas Medical Center · Kansas City, United States
  • Brigham and Women's Hospital · Boston, United States
  • Detroit Clinical Research Center, PC · Farmington Hills, United States
  • Mayo Clinic · Rochester, United States
  • NYU Medical Center - Dysautonomia center · New York, United States
  • Columbia University Medical Center - The Neurological Institute of New York · New York, United States
  • Duke University School of Medicine - Duke Neurological Disorders Clinic - Morreene Road Location · Durham, United States
  • Penn State Milton S. Hershey Medical Center · Hershey, United States
  • University Of Pittsburgh · Pittsburgh, United States
  • Vanderbilt University Medical Center (VUMC) · Nashville, United States
  • Texas Movement Disorder Specialists · Georgetown, United States
  • Integrated Neurology Services · Alexandria, United States
  • Inland Northwest Research · Spokane, United States
  • Centre Hospitalier Universitaire (CHU) de Bordeaux · Bordeaux, France
  • CHU de Caen · Caen, France
  • CHU - Hospital de la Timone · Marseille, France
  • Chu De La Pitie-Salpetriere · Paris, France
  • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan · Toulouse, France
  • Kliniken Beelitz GmbH - Neurologisches Fachkrankenhaus fuer Bewegungsstoerungen / Parkinson · Beelitz, Germany
  • Universitatsklinikum Carl Gustav Carus an der Technischen Universitat Dresden · Dresden, Germany
  • University Hospital Duesseldorf · Düsseldorf, Germany
  • Paracelsus-Elena-Klinik · Kassel, Germany
  • Universitaetsklinikum Leipzig · Leipzig, Germany
  • Universitatsklinikum Giessen und Marburg GmbH · Marburg, Germany
  • …and 31 more on the registry record
Show 61 removed
  • Teva Investigational Site 15554 · La Jolla, United States
  • Teva Investigational Site 15547 · Washington D.C., United States
  • Teva Investigational Site 15555 · Tampa, United States
  • Teva Investigational Site 15550 · Chicago, United States
  • Teva Investigational Site 15546 · Kansas City, United States
  • Teva Investigational Site 15736 · Boston, United States
  • Teva Investigational Site 15552 · Rochester, United States
  • Teva Investigational Site 15549 · New York, United States
  • Teva Investigational Site 15551 · New York, United States
  • Teva Investigational Site 15553 · Durham, United States
  • Teva Investigational Site 15548 · Pittsburgh, United States
  • Teva Investigational Site 15874 · Nashville, United States
  • Teva Investigational Site 35290 · Bordeaux, France
  • Teva Investigational Site 35300 · Caen, France
  • Teva Investigational Site 35289 · Marseille, France
  • Teva Investigational Site 35291 · Paris, France
  • Teva Investigational Site 35292 · Toulouse, France
  • Teva Investigational Site 32823 · Beelitz, Germany
  • Teva Investigational Site 32818 · Dresden, Germany
  • Teva Investigational Site 32822 · Düsseldorf, Germany
  • Teva Investigational Site 32825 · Kassel, Germany
  • Teva Investigational Site 32826 · Leipzig, Germany
  • Teva Investigational Site 32824 · Marburg, Germany
  • Teva Investigational Site 32820 · München, Germany
  • Teva Investigational Site 32819 · Münster, Germany
  • Teva Investigational Site 32821 · Ulm, Germany
  • Teva Investigational Site 80203 · Haifa, Israel
  • Teva Investigational Site 80215 · Jerusalem, Israel
  • Teva Investigational Site 80204 · Tel Aviv, Israel
  • Teva Investigational Site 30299 · Bologna, Italy
  • …and 31 more on the registry record
across 2 updates, Nov 3, 2026 – Nov 5, 2026
Enrollment
350 (estimated)→349 (actual)
Oct 7, 2026
Show all 3 updates
  1. Nov 5, 2026
    7 sites removed
    Show 7 removed
    • Teva Investigational Site 15545 · Los Angeles, United States
    • Teva Investigational Site 15544 · Boca Raton, United States
    • Teva Investigational Site 15870 · Farmington Hills, United States
    • Teva Investigational Site 15735 · Hershey, United States
    • Teva Investigational Site 15869 · Georgetown, United States
    • Teva Investigational Site 15873 · Alexandria, United States
    • Teva Investigational Site 15543 · Spokane, United States
  2. Nov 3, 2026
    61 sites added, 54 sites removed
    Show 61 added (19 United States, 11 Spain, 9 Germany, 7 Japan, 6 Italy, 5 France, 3 Israel, 1 Serbia)
    • University of California - San Diego · La Jolla, United States
    • University California Los Angeles Medical Center (Ucla) · Los Angeles, United States
    • MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH) · Washington D.C., United States
    • Parkinson's Disease And Movement Disorder Center Of Boca Raton · Boca Raton, United States
    • University of South Florida Parkinson's Disease and Movement Disorders Center · Tampa, United States
    • Rush University Medical Center-Allergy/ Immunology Center · Chicago, United States
    • University of Kansas Medical Center · Kansas City, United States
    • Brigham and Women's Hospital · Boston, United States
    • Detroit Clinical Research Center, PC · Farmington Hills, United States
    • Mayo Clinic · Rochester, United States
    • NYU Medical Center - Dysautonomia center · New York, United States
    • Columbia University Medical Center - The Neurological Institute of New York · New York, United States
    • Duke University School of Medicine - Duke Neurological Disorders Clinic - Morreene Road Location · Durham, United States
    • Penn State Milton S. Hershey Medical Center · Hershey, United States
    • University Of Pittsburgh · Pittsburgh, United States
    • Vanderbilt University Medical Center (VUMC) · Nashville, United States
    • Texas Movement Disorder Specialists · Georgetown, United States
    • Integrated Neurology Services · Alexandria, United States
    • Inland Northwest Research · Spokane, United States
    • Centre Hospitalier Universitaire (CHU) de Bordeaux · Bordeaux, France
    • CHU de Caen · Caen, France
    • CHU - Hospital de la Timone · Marseille, France
    • Chu De La Pitie-Salpetriere · Paris, France
    • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan · Toulouse, France
    • Kliniken Beelitz GmbH - Neurologisches Fachkrankenhaus fuer Bewegungsstoerungen / Parkinson · Beelitz, Germany
    • Universitatsklinikum Carl Gustav Carus an der Technischen Universitat Dresden · Dresden, Germany
    • University Hospital Duesseldorf · Düsseldorf, Germany
    • Paracelsus-Elena-Klinik · Kassel, Germany
    • Universitaetsklinikum Leipzig · Leipzig, Germany
    • Universitatsklinikum Giessen und Marburg GmbH · Marburg, Germany
    • …and 31 more on the registry record
    Show 54 removed
    • Teva Investigational Site 15554 · La Jolla, United States
    • Teva Investigational Site 15547 · Washington D.C., United States
    • Teva Investigational Site 15555 · Tampa, United States
    • Teva Investigational Site 15550 · Chicago, United States
    • Teva Investigational Site 15546 · Kansas City, United States
    • Teva Investigational Site 15736 · Boston, United States
    • Teva Investigational Site 15552 · Rochester, United States
    • Teva Investigational Site 15549 · New York, United States
    • Teva Investigational Site 15551 · New York, United States
    • Teva Investigational Site 15553 · Durham, United States
    • Teva Investigational Site 15548 · Pittsburgh, United States
    • Teva Investigational Site 15874 · Nashville, United States
    • Teva Investigational Site 35290 · Bordeaux, France
    • Teva Investigational Site 35300 · Caen, France
    • Teva Investigational Site 35289 · Marseille, France
    • Teva Investigational Site 35291 · Paris, France
    • Teva Investigational Site 35292 · Toulouse, France
    • Teva Investigational Site 32823 · Beelitz, Germany
    • Teva Investigational Site 32818 · Dresden, Germany
    • Teva Investigational Site 32822 · Düsseldorf, Germany
    • Teva Investigational Site 32825 · Kassel, Germany
    • Teva Investigational Site 32826 · Leipzig, Germany
    • Teva Investigational Site 32824 · Marburg, Germany
    • Teva Investigational Site 32820 · München, Germany
    • Teva Investigational Site 32819 · Münster, Germany
    • Teva Investigational Site 32821 · Ulm, Germany
    • Teva Investigational Site 80203 · Haifa, Israel
    • Teva Investigational Site 80215 · Jerusalem, Israel
    • Teva Investigational Site 80204 · Tel Aviv, Israel
    • Teva Investigational Site 30299 · Bologna, Italy
    • …and 24 more on the registry record
    + 1 other change: verification date
  3. Oct 7, 2026
    Recruiting→Active, not recruiting
    Enrollment 350 (estimated)→349 (actual)
    + 4 other changes: identifiers, verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06568237
Responsible party
Sponsor
First posted
Aug 23, 2024
Start date
Oct 2, 2024
Primary completion
Sep 15, 2027 (estimated)
Completion
Sep 15, 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Tev Medical Expert, Study Director
study director · Teva Branded Pharmaceutical Products R&D LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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