Recruiting
Phase 2

TEV-56286

Sponsor:

Teva Branded Pharmaceutical Products R&D LLC

Code:

NCT06568237

Conditions

Multiple System Atrophy

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

TEV-56286

Placebo

Study Details

Brief 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.

Conditions

Multiple System Atrophy

Study ID

NCT06568237

Start date

Oct 2, 2024

Status verified date

Jul, 2026

Completion date

Sep 15, 2027

Anticipated

Primary completion date

Sep 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TEV-56286

Orally administered capsules once daily

placebo comparator: Placebo

Orally administered capsules once daily

Interventions

TEV-56286

TEV-56286 capsules administered orally

Placebo

Matching placebo administered orally

Primary outcome measure

  • 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 ]
  • For EU: Change From Baseline in the Total UMSARS Score Part I and Part II Combined [ Time Frame: Baseline to Week 48 ]

Central Contacts and Locations

Central contacts

Teva U.S. Medical Information

1-888-483-8279USMedInfo@tevapharm.com

Locations

Teva Investigational Site 15554

Recruiting

La Jolla, California, United States, 92037

Teva Investigational Site 15547

Recruiting

Washington D.C., District of Columbia, United States, 20007

Teva Investigational Site 15555

Recruiting

Tampa, Florida, United States, 33613

Teva Investigational Site 15550

Recruiting

Chicago, Illinois, United States, 60612-3852

Teva Investigational Site 15546

Recruiting

Kansas City, Kansas, United States, 66160

Teva Investigational Site 15736

Recruiting

Boston, Massachusetts, United States, 02115

Teva Investigational Site 15552

Recruiting

Rochester, Minnesota, United States, 55905

Teva Investigational Site 15549

Recruiting

New York, New York, United States, 10016

Teva Investigational Site 15551

Recruiting

New York, New York, United States, 10032-3726

Teva Investigational Site 15548

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Teva Investigational Site 15874

Recruiting

Nashville, Tennessee, United States, 37212

More Information

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • Multiple System Atrophy (MSA)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Teva Branded Pharmaceutical Products R&D LLC on 2026-07-20.