Recruiting
Phase 2

TEV-56286

Sponsor:

Teva Branded Pharmaceutical Products R&D LLC

Code:

NCT07197866

Conditions

Multiple System Atrophy

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

TEV-56286

Study Details

Brief summary:

The primary objective of the trial is to describe the long-term safety and tolerability of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA).

A secondary objective of the trial is to further describe the safety and tolerability of TEV-56286.

The planned total duration of the trial is approximately 100 weeks.

Conditions

Multiple System Atrophy

Study ID

NCT07197866

Start date

Sep 30, 2025

Status verified date

Aug, 2026

Completion date

May 17, 2029

Anticipated

Primary completion date

May 3, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Completion of the treatment period and the week 48(V9) visit of the double-blind trial (TV56286-NDG-20039) whilst remaining compliant with trial requirements
  • Females of childbearing potential may be included only if they have a negative pregnancy test at the baseline visit
  • Females of childbearing potential whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the trial and for 28 days after the last does of IMP
  • Males who are potentially fertile/reproductively competent (not surgically \[eg, vasectomy\] or congenitally sterile) and their female partners who are of childbearing potential must use, together with their female partners, highly effective birth control methods for the duration of the trial and for 28 days after the last dose of investigational medicinal product

NOTE - Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • Is a female participant who is pregnant, plans to become pregnant, or is breastfeeding during the trial
  • Is of a vulnerable population (eg, people kept in detention or jail)
  • Is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this trial

Note - Additional criteria apply, please contact the investigator for more information

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TEV-56286

Interventions

TEV-56286

administered orally

Primary outcome measure

  • Number of participants experiencing an adverse event [ Time Frame: Baseline to Week 100 ]
  • Number of participants who withdrew from the trial due to an adverse event [ Time Frame: Baseline to Week 100 ]

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 15544

Recruiting

Boca Raton, Florida, United States, 33486

Teva Investigational Site 15555

Recruiting

Tampa, Florida, United States, 33613

Teva Investigational Site 15546

Recruiting

Kansas City, Kansas, United States, 66160

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 15543

Recruiting

Spokane, Washington, United States, 99202

More Information

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Teva Branded Pharmaceutical Products R&D LLC on 2026-08-31.