Multiple System AtrophyPhase 2TOPAS-MSANCT06568237
A Trial to Test if TEV-56286 is Effective for Treatment of Participants With 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 61 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- 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?
- Yes, some participants may receive a placebo
- How many people
- 349 participants
- Where
- 61 sitesin 8 countries
- Study dates
- 2 Oct 2024to 15 Sep 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
61 sites in 8 countries.
61 sites in 8 countries
United States19 sites
Teva Investigational Site 15873
Alexandria, Virginia, 22310
Teva Investigational Site 15544
Boca Raton, Florida, 33486
Teva Investigational Site 15736
Boston, Massachusetts, 02115
Teva Investigational Site 15550
Chicago, Illinois, 60612-3852
Teva Investigational Site 15553
Durham, North Carolina, 27705-4410
Teva Investigational Site 15870
Farmington Hills, Michigan, 48334
Teva Investigational Site 15869
Georgetown, Texas, 78628
Teva Investigational Site 15735
Hershey, Pennsylvania, 17033
Teva Investigational Site 15546
Kansas City, Kansas, 66160
Teva Investigational Site 15554
La Jolla, California, 92037
Teva Investigational Site 15545
Los Angeles, California, 90095
Teva Investigational Site 15874
Nashville, Tennessee, 37212
Teva Investigational Site 15549
New York, New York, 10016
Teva Investigational Site 15551
New York, New York, 10032-3726
Teva Investigational Site 15548
Pittsburgh, Pennsylvania, 15213
Teva Investigational Site 15552
Rochester, Minnesota, 55905
Teva Investigational Site 15543
Spokane, Washington, 99202
Teva Investigational Site 15555
Tampa, Florida, 33613
Teva Investigational Site 15547
Washington D.C., District of Columbia, 20007
Spain11 sites
Teva Investigational Site 31328
Barakaldo, 48903
Teva Investigational Site 31323
Barcelona, 08035
Teva Investigational Site 31321
Barcelona, 08036
Teva Investigational Site 31324
Barcelona, 08041
Teva Investigational Site 31329
Elche, 03203
Teva Investigational Site 31327
Madrid, 28006
Teva Investigational Site 31330
Madrid, 28034
Teva Investigational Site 31331
Madrid, 28041
Teva Investigational Site 31320
Pamplona, 31008
Teva Investigational Site 31322
Seville, 41015
Teva Investigational Site 31319
Valencia, 46026
Germany9 sites
Teva Investigational Site 32823
Beelitz, 14547
Teva Investigational Site 32818
Dresden, 01307
Teva Investigational Site 32822
Düsseldorf, 40225
Teva Investigational Site 32825
Kassel, 34128
Teva Investigational Site 32826
Leipzig, 04103
Teva Investigational Site 32824
Marburg, 35033
Teva Investigational Site 32820
München, 81377
Teva Investigational Site 32819
Münster, 48149
Teva Investigational Site 32821
Ulm, 89081
Japan7 sites
Teva Investigational Site 84140
Chiba, 260-8677
Teva Investigational Site 84139
Fuchū, 183-0042
Teva Investigational Site 84136
Gifu, 501-1112
Teva Investigational Site 84137
Niigata, 951-8520
Teva Investigational Site 84138
Sagamihara, 252-0392
Teva Investigational Site 84141
Sanda-shi, 669-1592
Teva Investigational Site 84135
Sendai, 982-8555
Italy6 sites
Teva Investigational Site 30299
Bologna, 40139
Teva Investigational Site 30297
Catania, 95123
Teva Investigational Site 30298
Milan, 20132
Teva Investigational Site 30294
Padova, 35127
Teva Investigational Site 30296
Roma, 00163
Teva Investigational Site 30295
Salerno, 84131
France5 sites
Teva Investigational Site 35290
Bordeaux, 33400
Teva Investigational Site 35300
Caen, 14033
Teva Investigational Site 35289
Marseille, 13385
Teva Investigational Site 35291
Paris, 75651 Cedex 13
Teva Investigational Site 35292
Toulouse, 31059
Israel3 sites
Teva Investigational Site 80203
Haifa, 31999
Teva Investigational Site 80215
Jerusalem, 9103102
Teva Investigational Site 80204
Tel Aviv, 6423906
About this study
Official title: 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.
Read the detailed description
We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, Japan, and Serbia.
- Conditions
- Multiple System Atrophy
- Being tested
- TEV-56286, Placebo
- Keywords
- Multiple System Atrophy (MSA)
- 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, anle138b
TEV-56286 capsules administered orally
PlaceboDrug
Matching placebo administered orally
| Study group | Role | What they receive |
|---|---|---|
| TEV-56286 | Experimental | Orally administered capsules once daily Receives: Drug: TEV-56286 |
| Placebo | Placebo comparator | Orally administered capsules once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to Week 48
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).
Measured: Baseline to Week 48
Secondary outcomes (19)
For non-EU: Change From Baseline in the Total UMSARS Score (Part I and Part II combined)
Measured: Baseline to Week 48
For EU: Change From Baseline in the Modified UMSARS part I score (excluding item 11, item scoring rescaled 0-3)
Measured: Baseline to Week 48
Change From Baseline in the UMSARS Part 1 Score
Measured: Baseline to Week 48
Change From Baseline in Lateral Ventricle Volume Measured by MRI
Measured: Baseline to Week 48
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
Measured: Baseline to Week 48
Change From Baseline in the Neurofilament Light Chain (NfL) Concentrations in Cerebrospinal Fluid (CSF)
Measured: Baseline to Week 48
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)
Measured: Baseline to Week 48
Change From Baseline in the Pons volume measured by MRI
Measured: Baseline to Week 48
Change From Baseline in the Cerebellar volume measured by MRI
Measured: Baseline to Week 48
Change From Baseline in the UMSARS part II score
Measured: Baseline to Week 48
Change From Baseline in the UMSARS part IV score
Measured: Baseline to Week 48
Change From Baseline in the Two-minute walk test as part of gait assessment
Measured: Baseline to Week 48
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.
Measured: Baseline to Week 48
Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAEs)
Measured: Up to Week 48
Number of Participants Who Withdraw From the Study Due to an Adverse Event
Measured: Up to Week 48
Number of Participants Who Withdraw From Treatment Due to an Adverse Event
Measured: Up to Week 48
Number of Participants With At Least One Potentially Clinically Significant Abnormal Vital Sign Value
Measured: Up to Week 48
Number of Participants With At Least One Potentially Clinically Significant Laboratory Test Value
Measured: Up to Week 48
Number of Participants with at Least One Potentially Clinically Significant Change in 12-lead Electrocardiogram (ECG) Findings
Measured: Up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start2 Oct 2024
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tev Medical Expert, Study Director, Study director, Teva Branded Pharmaceutical Products R&D LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568237
- Sponsor's protocol ID
- TV56286-NDG-20039
- Other IDs
- 2023-505320-54-00, 2023
- Acronym
- TOPAS-MSA
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2024
- 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
- 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)
- ClinicalTrials.gov ID
- NCT06568237
- Acronym / sponsor ID
- TOPAS-MSA / TV56286-NDG-20039
- Conditions
- Multiple System Atrophy
- Keywords
- Multiple System Atrophy (MSA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 23 Aug 2024 (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 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.
Detailed description
We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, Japan, and Serbia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEV-56286 | Experimental | Drug: TEV-56286Orally administered capsules once daily |
| Placebo | Placebo comparator | Drug: PlaceboOrally administered capsules once daily |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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: emrusolmin, anle138bTEV-56286 capsules administered orally | Drug | TEV-56286 |
| PlaceboMatching placebo administered orally | Drug | Placebo |
Primary outcome
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).
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).
19 secondary outcomes
For non-EU: Change From Baseline in the Total UMSARS Score (Part I and Part II combined)
Time frame: 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
Change From Baseline in the UMSARS Part 1 Score
Time frame: Baseline to Week 48
Change From Baseline in Lateral Ventricle Volume Measured by MRI
Time frame: Baseline to Week 48
Change From Baseline in the Clinical Global Impression - Severity scale (CGI-S)
Time frame: Baseline to Week 48
Change From Baseline in the Neurofilament Light Chain (NfL) Concentrations in Cerebrospinal Fluid (CSF)
Time frame: Baseline to Week 48
Change From Baseline in the Patient Global Impression-Severity Scale (PGI-S)
Time frame: Baseline to Week 48
Change From Baseline in the Pons volume measured by MRI
Time frame: Baseline to Week 48
Change From Baseline in the Cerebellar volume measured by MRI
Time frame: Baseline to Week 48
Change From Baseline in the UMSARS part II score
Time frame: Baseline to Week 48
Change From Baseline in the UMSARS part IV score
Time frame: Baseline to Week 48
Change From Baseline in the Two-minute walk test as part of gait assessment
Time frame: Baseline to Week 48
Change From Baseline in the Multiple System Atrophy - Quality of Life (MSA-QoL) Score
Time frame: Baseline to Week 48
Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAEs)
Time frame: Up to Week 48
Number of Participants Who Withdraw From the Study Due to an Adverse Event
Time frame: Up to Week 48
Number of Participants Who Withdraw From Treatment Due to an Adverse Event
Time frame: Up to Week 48
Number of Participants With At Least One Potentially Clinically Significant Abnormal Vital Sign Value
Time frame: Up to Week 48
Number of Participants With At Least One Potentially Clinically Significant Laboratory Test Value
Time frame: 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
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.
- Teva MSA TrialLink provided by the sponsor.
- TOPAS-MSA Web SiteLink provided by the sponsor.
- Teva MSA Trial EU LocationsLink provided by the sponsor.
- 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.
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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. This study is not recruiting at the moment.
Tev Medical Expert, Study Director study director
Teva Branded Pharmaceutical Products R&D LLC
61 sites in 8 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 61 sites in 8 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 6 inclusion and 8 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: under way, not looking for participants, 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 61 sites in United States, Spain, Germany, Japan, Italy and 3 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 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.