Multiple System AtrophyPhase 2NCT07197866
An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy
A Phase 2 study testing TEV-56286 in people with Multiple System Atrophy, run by Teva Branded Pharmaceutical Products R&D LLC at 41 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Multiple System Atrophy
- What is being tested?
- TEV-56286
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 41 sitesin 7 countries
- Study dates
- 30 Sep 2025to 17 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 childbearing potential 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 birth control 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 investigational medicinal product
- NOTE - Additional criteria apply, please contact the investigator for more information
Who cannot join
- 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
Trial locations and contacts
41 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
41 sites in 7 countries
United States10 sites, 10 recruiting
- Recruiting
Teva Investigational Site 15544
Boca Raton, Florida, 33486
- Recruiting
Teva Investigational Site 15550
Chicago, Illinois, 60612-3852
- Recruiting
Teva Investigational Site 15553
Durham, North Carolina, 27705-4410
- Recruiting
Teva Investigational Site 15546
Kansas City, Kansas, 66160
- Recruiting
Teva Investigational Site 15554
La Jolla, California, 92037
- Recruiting
Teva Investigational Site 15549
New York, New York, 10016
- Recruiting
Teva Investigational Site 15551
New York, New York, 10032-3726
- Recruiting
Teva Investigational Site 15548
Pittsburgh, Pennsylvania, 15213
- Recruiting
Teva Investigational Site 15543
Spokane, Washington, 99202
- Recruiting
Teva Investigational Site 15555
Tampa, Florida, 33613
Spain7 sites, 7 recruiting
- Recruiting
Teva Investigational Site 31324
Barcelona, 08025
- Recruiting
Teva Investigational Site 31323
Barcelona, 08035
- Recruiting
Teva Investigational Site 31321
Barcelona, 08036
- Recruiting
Teva Investigational Site 31327
Madrid, 28006
- Recruiting
Teva Investigational Site 31320
Pamplona, 31008
- Recruiting
Teva Investigational Site 31322
Seville, 41013
- Recruiting
Teva Investigational Site 31319
Valencia, 46026
Germany6 sites, 6 recruiting
- Recruiting
Teva Investigational Site 32818
Dresden, 01307
- Recruiting
Teva Investigational Site 32822
Düsseldorf, 40225
- Recruiting
Teva Investigational Site 32825
Kassel, 34128
- Recruiting
Teva Investigational Site 32824
Marburg, 35033
- Recruiting
Teva Investigational Site 32820
München, 81377
- Recruiting
Teva Investigational Site 32819
Münster, 48149
Italy6 sites, 6 recruiting
- Recruiting
Teva Investigational Site 30299
Bologna, 40139
- Recruiting
Teva Investigational Site 30297
Catania, 95123
- Recruiting
Teva Investigational Site 30298
Milan, 20132
- Recruiting
Teva Investigational Site 30294
Padova, 35127
- Recruiting
Teva Investigational Site 30296
Roma, 00163
- Recruiting
Teva Investigational Site 30295
Salerno, 84131
Japan6 sites, 6 recruiting
- Recruiting
Teva Investigational Site 84140
Chiba, 260-8677
- Recruiting
Teva Investigational Site 84139
Fuchū, 183-0042
- Recruiting
Teva Investigational Site 84137
Niigata, 951-8520
- Recruiting
Teva Investigational Site 84138
Sagamihara, 252-0392
- Recruiting
Teva Investigational Site 84141
Sanda-shi, 669-1592
- Recruiting
Teva Investigational Site 84135
Sendai, 982-8555
France4 sites, 4 recruiting
- Recruiting
Teva Investigational Site 35290
Bordeaux, 33400
- Recruiting
Teva Investigational Site 35289
Marseille, 13385
- Recruiting
Teva Investigational Site 35291
Paris, 75651
- Recruiting
Teva Investigational Site 35292
Toulouse, 31059
Israel2 sites, 2 recruiting
- Recruiting
Teva Investigational Site 80203
Haifa, 31999
- Recruiting
Teva Investigational Site 80204
Tel Aviv, 6423906
About this study
Official title: An Open-Label Extension, Multi-Centered, Phase 2 Trial to Describe the Safety and Efficacy of TEV-56286 (Emrusolmin) in Participants With Multiple System Atrophy
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.
- Conditions
- Multiple System Atrophy
- Being tested
- TEV-56286
- Medical subject headings
- Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEV-56286Drug
Also called Emrusolmin
administered orally
| Study group | Role | What they receive |
|---|---|---|
| TEV-56286 | Experimental | Not described Receives: Drug: TEV-56286 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing an adverse event
Measured: Baseline to Week 100
Number of participants who withdrew from the trial due to an adverse event
Measured: Baseline to Week 100
Secondary outcomes (3)
Number of participants with potentially clinically significant vital sign values
Measured: Baseline to Week 96
Number of participants with potentially clinically significant laboratory test values (hematology and chemistry)
Measured: Baseline to Week 96
Number of participants with potentially clinically significant 12-lead ECG measurements
Measured: Baseline to Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start30 Sep 2025
- Primary completion3 May 2029 (estimated)
- Study completion17 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197866
- Sponsor's protocol ID
- TV56286-NDG-20041
- Other IDs
- 2025-521642-14-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension, Multi-Centered, Phase 2 Trial to Describe the Safety and Efficacy of TEV-56286 (Emrusolmin) in Participants With Multiple System Atrophy
- ClinicalTrials.gov ID
- NCT07197866
- Acronym / sponsor ID
- TV56286-NDG-20041
- Conditions
- Multiple System Atrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 3 May 2029 (estimated)
- Study completion
- 17 May 2029 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEV-56286 | Experimental | Drug: TEV-56286 |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 childbearing potential 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 birth control 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 investigational medicinal product
- NOTE - Additional criteria apply, please contact the investigator for more information
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEV-56286Also: Emrusolminadministered orally | Drug | TEV-56286 |
Primary outcome
Number of participants experiencing an adverse event
Time frame: Baseline to Week 100
Number of participants who withdrew from the trial due to an adverse event
Time frame: Baseline to Week 100
3 secondary outcomes
Number of participants with potentially clinically significant vital sign values
Time frame: Baseline to Week 96
Number of participants with potentially clinically significant laboratory test values (hematology and chemistry)
Time frame: Baseline to Week 96
Number of participants with potentially clinically significant 12-lead ECG measurements
Time frame: Baseline to Week 96
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: 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.
Related trials for Multiple System Atrophy
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A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA)
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A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
Multiple System Atrophy
Enrolling by invitationPhase 2
Open-Label Access to ATH434 for Patients Who Completed Study ATH434-201 in France
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Tributyrin for Progressive Supranuclear Palsy (PSP): Virtual Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D LLC
41 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TEV-56286 in people with Multiple System Atrophy, run by Teva Branded Pharmaceutical Products R&D LLC at 41 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Spain, Germany, Italy, Japan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teva U.S. Medical Information (1-888-483-8279, USMedInfo@tevapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants experiencing an adverse event (time frame: Baseline to Week 100). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.