NCT06568237 · Teva Branded Pharmaceutical Products R&D, Inc.
A Study to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy (MSA): A Safety and Efficacy Study
(TOPAS-MSA)
What this study is about
The primary objective of the study is to evaluate the effectiveness of TEV-56286 administered taken by mouth for the treatment of adult participants with Multiple System Atrophy (MSA). A secondary objective of the study is to evaluate specific effectiveness parameters of TEV-56286. Another secondary objective is to evaluate the safety and how well patients handle the treatment of TEV-56286.
View original scientific description
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.
Interventions
DRUG
TEV-56286
TEV-56286 capsules administered orally
DRUG
Placebo
Matching placebo administered orally
Primary outcome measures
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria
- is able to ambulate at least 10 meters without the assistance of another person at screening; the use of assistive device (eg, cane, not walker) is allowed
- 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 inve
Where
- La Jolla, California
- Los Angeles, California
- Washington D.C., District of Columbia
- Boca Raton, Florida
- Tampa, Florida
- Chicago, Illinois
- Kansas City, Kansas
- Boston, Massachusetts
- Farmington Hills, Michigan
- Rochester, Minnesota
- New York, New York
- Durham, North Carolina
And 6 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations