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Testing TEV-56286 for treating Multiple System Atrophy

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)

PHASE2 · Teva Branded Pharmaceutical Products R&D, Inc. · NCT06568237

This study is testing a new oral medication called TEV-56286 to see if it can help adults with Multiple System Atrophy feel better over a 56-week period.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment350 (estimated)
Ages30 Years to 75 Years
SexAll
SponsorTeva Branded Pharmaceutical Products R&D, Inc. (industry)
Locations54 sites (La Jolla, California and 53 other locations)
Trial IDNCT06568237 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of TEV-56286, an oral medication, in treating adults diagnosed with Multiple System Atrophy (MSA). Participants will undergo a 56-week study period, which includes a screening phase, a 48-week double-blind treatment phase, and a follow-up visit. The study aims to assess both the efficacy and safety of TEV-56286, with specific efficacy parameters also being evaluated. The trial will take place across multiple countries including the US, Israel, Italy, Spain, Germany, France, and Japan.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with clinically possible or probable MSA who can ambulate at least 10 meters without assistance.

Not a fit: Patients with severe mobility limitations or those not meeting the diagnostic criteria for MSA may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief for patients suffering from Multiple System Atrophy.

How similar studies have performed: While there have been studies on MSA treatments, the specific approach with TEV-56286 is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

La Jolla, California and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Multiple System Atrophy

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.