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

RecruitingPhase 2

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)

Who can join

Ages 30 to 75 · All sexes

Full eligibility 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

About the study

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.

What is being tested

Sponsor: Teva Branded Pharmaceutical Products R&D LLC · Participants: 350 · Started: Oct 2, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06568237

Locations in the U.S.

CaliforniaTeva Investigational Site 15554, La Jolla
Teva Investigational Site 15545, Los Angeles (Not yet recruiting)
District of ColumbiaTeva Investigational Site 15547, Washington D.C.
FloridaTeva Investigational Site 15555, Tampa
IllinoisTeva Investigational Site 15550, Chicago
KansasTeva Investigational Site 15546, Kansas City
MassachusettsTeva Investigational Site 15736, Boston
MichiganTeva Investigational Site 15870, Farmington Hills (Not yet recruiting)
MinnesotaTeva Investigational Site 15552, Rochester
New YorkTeva Investigational Site 15549, New York
Teva Investigational Site 15551, New York
PennsylvaniaTeva Investigational Site 15735, Hershey (Not yet recruiting)
Teva Investigational Site 15548, Pittsburgh
TennesseeTeva Investigational Site 15874, Nashville
TexasTeva Investigational Site 15869, Georgetown (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.