ClinicalTrials.gg
RecruitingNCT07197866Updated Oct 9, 2026

An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy

A Phase 2 interventional study of TEV-56286 in Multiple System Atrophy, sponsored by Teva Branded Pharmaceutical Products R&D LLC. Recruiting at 41 sites in 7 countries. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.

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

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
Updated Oct 9, 2026Site recruiting status changed5 sites addedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
30 Years and older
Sex
All
01

Study summary

The primary objective of the trial is to describe the long-term safety and tolerability of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA).

A secondary objective of the trial is to further describe the safety and tolerability of TEV-56286.

The planned total duration of the trial is approximately 100 weeks.

02

Conditions studied

  • Multiple System Atrophy
03

In context

Multiple System Atrophy

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

This study's planned enrollment of 200 is above the median of 41 across 134 interventional studies indexed under Multiple System Atrophy.

Browse Multiple System Atrophy studies →

Lead sponsor

Teva Branded Pharmaceutical Products R&D LLC is the lead sponsor of 24 studies on the registry; 7 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
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

  • Completion of the treatment period and the week 48(V9) visit of the double-blind trial (TV56286-NDG-20039) whilst remaining compliant with trial requirements
  • Females of may be included only if they have a negative pregnancy test at the baseline visit
  • Females of childbearing potential whose male partners are potentially fertile (ie, no vasectomy) must use highly effective methods for the duration of the trial and for 28 days after the last does of IMP
  • Males who are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners who are of childbearing potential must use, together with their female partners, highly effective birth control methods for the duration of the trial and for 28 days after the last dose of medicinal product

NOTE - Additional criteria apply, please contact the investigator for more information

Exclusion criteria

Exclusion Criteria:

  • Is a female participant who is pregnant, plans to become pregnant, or is breastfeeding during the trial
  • Is of a vulnerable population (eg, people kept in detention or jail)
  • Is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this trial

Note - Additional criteria apply, please contact the investigator for more information

Terms in these criteria, in plain language(3)

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

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.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    TEV-56286

    Drug: TEV-56286

Interventions

  • DrugTEV-56286

    administered orally

    Also known as: Emrusolmin

06

What researchers measure

Primary outcomes

  1. Number of participants experiencing an adverse event

    Time frame: Baseline to Week 100

  2. Number of participants who withdrew from the trial due to an adverse event

    Time frame: Baseline to Week 100

Secondary outcomes

  1. Number of participants with potentially clinically significant vital sign values

    Time frame: Baseline to Week 96

  2. Number of participants with potentially clinically significant laboratory test values (hematology and chemistry)

    Time frame: Baseline to Week 96

  3. Number of participants with potentially clinically significant 12-lead ECG measurements

    Time frame: Baseline to Week 96

07

Study locations

41 of 41 sites recruiting
  • Teva Investigational Site 15554
    La Jolla, California 92037, United States
    Recruiting
  • Teva Investigational Site 15544
    Boca Raton, Florida 33486, United States
    Recruiting
  • Teva Investigational Site 15555
    Tampa, Florida 33613, United States
    Recruiting
  • Teva Investigational Site 15550
    Chicago, Illinois 60612-3852, United States
    Recruiting
  • Teva Investigational Site 15546
    Kansas City, Kansas 66160, United States
    Recruiting
  • Teva Investigational Site 15549
    New York, New York 10016, United States
    Recruiting
  • Teva Investigational Site 15551
    New York, New York 10032-3726, United States
    Recruiting
  • Teva Investigational Site 15553
    Durham, North Carolina 27705-4410, United States
    Recruiting
  • Teva Investigational Site 15548
    Pittsburgh, Pennsylvania 15213, United States
    Recruiting
  • Teva Investigational Site 15543
    Spokane, Washington 99202, United States
    Recruiting
  • Teva Investigational Site 35290
    Bordeaux, 33400, France
    Recruiting
  • Teva Investigational Site 35289
    Marseille, 13385, France
    Recruiting
  • Teva Investigational Site 35291
    Paris, 75651, France
    Recruiting
  • Teva Investigational Site 35292
    Toulouse, 31059, France
    Recruiting
  • Teva Investigational Site 32818
    Dresden, 01307, Germany
    Recruiting
  • Teva Investigational Site 32822
    Düsseldorf, 40225, Germany
    Recruiting
  • Teva Investigational Site 32825
    Kassel, 34128, Germany
    Recruiting
  • Teva Investigational Site 32824
    Marburg, 35033, Germany
    Recruiting
  • Teva Investigational Site 32820
    München, 81377, Germany
    Recruiting
  • Teva Investigational Site 32819
    Münster, 48149, Germany
    Recruiting
  • Teva Investigational Site 80203
    Haifa, 31999, Israel
    Recruiting
  • Teva Investigational Site 80204
    Tel Aviv, 6423906, Israel
    Recruiting
  • Teva Investigational Site 30299
    Bologna, 40139, Italy
    Recruiting
  • Teva Investigational Site 30297
    Catania, 95123, Italy
    Recruiting
  • Teva Investigational Site 30298
    Milan, 20132, Italy
    Recruiting
  • Teva Investigational Site 30294
    Padova, 35127, Italy
    Recruiting
  • Teva Investigational Site 30296
    Roma, 00163, Italy
    Recruiting
  • Teva Investigational Site 30295
    Salerno, 84131, Italy
    Recruiting
  • Teva Investigational Site 84140
    Chiba, 260-8677, Japan
    Recruiting
  • Teva Investigational Site 84139
    Fuchū, 183-0042, Japan
    Recruiting
  • Teva Investigational Site 84137
    Niigata, 951-8520, Japan
    Recruiting
  • Teva Investigational Site 84138
    Sagamihara, 252-0392, Japan
    Recruiting
  • Teva Investigational Site 84141
    Sanda-shi, 669-1592, Japan
    Recruiting
  • Teva Investigational Site 84135
    Sendai, 982-8555, Japan
    Recruiting
  • Teva Investigational Site 31324
    Barcelona, 08025, Spain
    Recruiting
  • Teva Investigational Site 31323
    Barcelona, 08035, Spain
    Recruiting
  • Teva Investigational Site 31321
    Barcelona, 08036, Spain
    Recruiting
  • Teva Investigational Site 31327
    Madrid, 28006, Spain
    Recruiting
  • Teva Investigational Site 31320
    Pamplona, 31008, Spain
    Recruiting
  • Teva Investigational Site 31322
    Seville, 41013, Spain
    Recruiting
  • Teva Investigational Site 31319
    Valencia, 46026, Spain
    Recruiting
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.

No publications or documents are linked to this record.

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 Sep 2025 (actual). Primary completion is estimated for May 2029, 43 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 43 months is above that.

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

Registered
Sep 26, 2025
First posted
Sep 29, 2025
StartActual
Sep 30, 2025
Primary completionEst.
May 3, 2029
CompletionEst.
May 17, 2029
Last update
Oct 9, 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.
Sites
5 sites added. 2 sites changed recruiting status (2 now recruiting)
Show 2 sites
  • Teva Investigational Site 35289 · Marseille, FranceNot yet recruiting→Recruiting
  • Teva Investigational Site 31327 · Madrid, SpainNot yet recruiting→Recruiting
Show 5 added (2 United States, 1 Italy, 1 Spain, 1 Japan)
  • Teva Investigational Site 15550 · Chicago, United States
  • Teva Investigational Site 15553 · Durham, United States
  • Teva Investigational Site 30294 · Padova, Italy
  • Teva Investigational Site 31327 · Madrid, Spain
  • Teva Investigational Site 84140 · Chiba, Japan
across 3 updates, Sep 28, 2026 – Oct 9, 2026
Show all 3 updates
  1. Oct 9, 2026
    Teva Investigational Site 31327 is now Recruiting
    + 1 other change: verification date
  2. Oct 2, 2026
    1 site added
    Show site
    • Teva Investigational Site 84140 · Chiba, Japan
  3. Sep 28, 2026
    4 sites added. Teva Investigational Site 35289 is now Recruiting
    Show 4 added (2 United States, 1 Italy, 1 Spain)
    • Teva Investigational Site 15550 · Chicago, United States
    • Teva Investigational Site 15553 · Durham, United States
    • Teva Investigational Site 30294 · Padova, Italy
    • Teva Investigational Site 31327 · Madrid, Spain

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
NCT07197866
Responsible party
Sponsor
First posted
Sep 29, 2025
Start date
Sep 30, 2025
Primary completion
May 3, 2029 (estimated)
Completion
May 17, 2029 (estimated)
Last update
Oct 9, 2026

Study contacts

Teva U.S. Medical Information
Contact
USMedInfo@tevapharm.com
1-888-483-8279
Teva Medical Expert, MD
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 ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion