> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-trial-to-test-if-tev-56286-is-effective-for-treatment-of-ec4394e6-61e8-48a0-a337-468112f685be > Record changed: 2026-10-13 # A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy NCT06568237 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) Participants 350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) Lead sponsor Teva Branded Pharmaceutical Products R&D LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) Start date 2024-10-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) Number of sites 61 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **Acronym** TOPAS-MSA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **Short title** A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) ## Dates **Completion date** 2027-09-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **First posted** 2024-08-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **Registry last updated** 2026-07-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **Primary completion date** 2027-09-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **Start date** 2024-10-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) ## Size and sites **Participants** 350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **Planned participants** 350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **Number of sites** 61 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **Lead sponsor** Teva Branded Pharmaceutical Products R&D LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) ## Identifiers **Registry ID** NCT06568237 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **ClinicalTrials.gov ID** NCT06568237 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) ## Outcomes ### 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) Timeframe: 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). 2. For EU: Change From Baseline in the Total UMSARS Score Part I and Part II Combined Timeframe: 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). ### Secondary outcomes 1. For non-EU: Change From Baseline in the Total UMSARS Score (Part I and Part II combined) Timeframe: 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) Timeframe: Baseline to Week 48 3. Change From Baseline in the UMSARS Part 1 Score Timeframe: Baseline to Week 48 4. Change From Baseline in Lateral Ventricle Volume Measured by MRI Timeframe: Baseline to Week 48 5. Change From Baseline in the Clinical Global Impression - Severity scale (CGI-S) Timeframe: 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 6. Change From Baseline in the Neurofilament Light Chain (NfL) Concentrations in Cerebrospinal Fluid (CSF) Timeframe: Baseline to Week 48 7. Change From Baseline in the Patient Global Impression-Severity Scale (PGI-S) Timeframe: 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) 8. Change From Baseline in the Pons volume measured by MRI Timeframe: Baseline to Week 48 9. Change From Baseline in the Cerebellar volume measured by MRI Timeframe: Baseline to Week 48 10. Change From Baseline in the UMSARS part II score Timeframe: Baseline to Week 48 11. Change From Baseline in the UMSARS part IV score Timeframe: Baseline to Week 48 12. Change From Baseline in the Two-minute walk test as part of gait assessment Timeframe: Baseline to Week 48 13. Change From Baseline in the Multiple System Atrophy - Quality of Life (MSA-QoL) Score Timeframe: 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. 14. Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAEs) Timeframe: Up to Week 48 15. Number of Participants Who Withdraw From the Study Due to an Adverse Event Timeframe: Up to Week 48 16. Number of Participants Who Withdraw From Treatment Due to an Adverse Event Timeframe: Up to Week 48 17. Number of Participants With At Least One Potentially Clinically Significant Abnormal Vital Sign Value Timeframe: Up to Week 48 18. Number of Participants With At Least One Potentially Clinically Significant Laboratory Test Value Timeframe: Up to Week 48 19. Number of Participants with at Least One Potentially Clinically Significant Change in 12-lead Electrocardiogram (ECG) Findings Timeframe: Up to Week 48 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 30 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) ## Sites - Teva Investigational Site 15554La Jolla, United StatesRecruiting - Teva Investigational Site 15545Los Angeles, United StatesNot yet recruiting - Teva Investigational Site 15547Washington D.C., United StatesRecruiting - Teva Investigational Site 15544Boca Raton, United StatesActive, not recruiting - Teva Investigational Site 15555Tampa, United StatesRecruiting - Teva Investigational Site 15550Chicago, United StatesRecruiting - Teva Investigational Site 15546Kansas City, United StatesRecruiting - Teva Investigational Site 15736Boston, United StatesRecruiting - Teva Investigational Site 15870Farmington Hills, United StatesNot yet recruiting - Teva Investigational Site 15552Rochester, United StatesRecruiting - Teva Investigational Site 15549New York, United StatesRecruiting - Teva Investigational Site 15551New York, United StatesRecruiting - Teva Investigational Site 15553Durham, United StatesActive, not recruiting - Teva Investigational Site 15735Hershey, United StatesNot yet recruiting - Teva Investigational Site 15548Pittsburgh, United StatesRecruiting - Teva Investigational Site 15874Nashville, United StatesRecruiting - Teva Investigational Site 15869Georgetown, United StatesNot yet recruiting - Teva Investigational Site 15873Alexandria, United StatesActive, not recruiting - Teva Investigational Site 15543Spokane, United StatesActive, not recruiting - Teva Investigational Site 35290Bordeaux, FranceRecruiting - Teva Investigational Site 35300Caen, FranceRecruiting - Teva Investigational Site 35289Marseille, FranceRecruiting - Teva Investigational Site 35291Paris, FranceRecruiting - Teva Investigational Site 35292Toulouse, FranceRecruiting - Teva Investigational Site 32823Beelitz, GermanyRecruiting And 36 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) ## References - Related resource (www.tevapharm.com) Source: [www.tevapharm.com](https://www.tevapharm.com/teva-clinical-trials/clinical-trials-results/clinical-trials/tv56286ndg20039) - Related resource (topas-msa-study.com) Source: [topas-msa-study.com](https://topas-msa-study.com/) - Related resource (euclinicaltrials.eu) Source: [euclinicaltrials.eu](https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2023-505320-54-00) ### Other registry identifiers (2) - 2023 - 2023-505320-54-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06568237) ## Related records ### Drugs (1) - [Emrusolmin](https://trialight.com/data/asset/emrusolmin-2bdd273e-d76b-47e7-9a2e-836afc733bd8.md) ### Lead sponsors (1) - [Teva Branded Pharmaceutical Products R&D, Inc.](https://trialight.com/data/company/teva-branded-pharmaceutical-products-r-d-inc-eb709623-d4a9-423d-9161-7b0540fb1b17.md) ### Conditions (1) - [Multiple system atrophy](https://trialight.com/data/condition/multiple-system-atrophy-6bf4f57c-d07e-5ddf-8d90-2a9958485dcc.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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