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TEV-56286 for Multiple System Atrophy

This study is testing if an oral capsule called TEV-56286 can effectively treat adults with Multiple System Atrophy (MSA). MSA is a rare, progressive neurological disorder that affects movement, balance, and automatic body functions. Researchers will compare TEV-56286 to a placebo (an inactive capsule that looks the same) to see if it improves symptoms. You may be able to join if you are between 30 and 75 years old and have a diagnosis of "clinically possible" or "clinically probable" MSA. The main way success will be measured is by looking at changes in your MSA symptoms over 48 weeks using a special rating scale. The study is currently recruiting participants.

Study design
This interventional study plans to enroll 350 participants. It compares TEV-56286 capsules to a matching placebo, both taken orally.
What's involved
The study involves a screening period of up to 4 weeks, followed by 48 weeks of treatment, and a follow-up visit approximately 4 weeks after treatment ends.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a follow-up visit approximately 4 weeks after the 48-week treatment period ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06568237

A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy

Recruiting
PHASE2Ages 30–75InterventionalTreatment
Teva Branded Pharmaceutical Products R&D LLC
~350 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:TEV-56286Placebo

At a glance

Recruiting sites
53 of 61 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
For non-EU: Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (excluding item 11)
Measured over Baseline to Week 48
+1 more outcome measured

Conditions

Multiple System Atrophy

Explore related trials

Multiple System Atrophy

Where it's being run

61 sites across 22 states
Spain11
Germany9
Japan7
Italy6
France5
Israel3
California2
Florida2

Study leadership

  • Tev Medical Expert, Study Director · STUDY_DIRECTOR · Teva Branded Pharmaceutical Products R&D LLC

Who to contact

Teva U.S. Medical Information
[email protected]
1-888-483-8279
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • For non-EU: Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (excluding item 11)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 CombinedBaseline 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).