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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Multiple System Atrophy

In brief

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.

Key facts

Study ID

NCT06568237

Run by

Teva Branded Pharmaceutical Products R&D LLC

People needed

350

Starts

2024-10-02

Expected to finish

2027-09-15

Last updated by the study team

2026-07-20

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Teva Investigational Site 32824 — Marburg, Germany (enrolling)
• Teva Investigational Site 32819 — Münster, Germany (enrolling)
• Teva Investigational Site 32826 — Leipzig, Germany (enrolling)
• Teva Investigational Site 15555 — Tampa, Florida, United States (enrolling)
• Teva Investigational Site 15547 — Washington D.C., District of Columbia, United States (enrolling)
• Teva Investigational Site 32820 — München, Germany (enrolling)
• Teva Investigational Site 32818 — Dresden, Germany (enrolling)
• Teva Investigational Site 32825 — Kassel, Germany (enrolling)
• Teva Investigational Site 15552 — Rochester, Minnesota, United States (enrolling)
• Teva Investigational Site 15549 — New York, New York, United States (enrolling)
• Teva Investigational Site 15551 — New York, New York, United States (enrolling)
• Teva Investigational Site 15550 — Chicago, Illinois, United States (enrolling)
• Teva Investigational Site 15546 — Kansas City, Kansas, United States (enrolling)
• Teva Investigational Site 15548 — Pittsburgh, Pennsylvania, United States (enrolling)
• Teva Investigational Site 15874 — Nashville, Tennessee, United States (enrolling)
• Teva Investigational Site 15736 — Boston, Massachusetts, United States (enrolling)
• Teva Investigational Site 15554 — La Jolla, California, United States (enrolling)
• Teva Investigational Site 32822 — Düsseldorf, Germany (enrolling)
• Teva Investigational Site 35290 — Bordeaux, France (enrolling)
• Teva Investigational Site 35300 — Caen, France (enrolling)
• Teva Investigational Site 35289 — Marseille, France (enrolling)
• Teva Investigational Site 35291 — Paris, France (enrolling)
• Teva Investigational Site 35292 — Toulouse, France (enrolling)
• Teva Investigational Site 32823 — Beelitz, Germany (enrolling)
• Teva Investigational Site 32821 — Ulm, Germany (enrolling)

Full record on ClinicalTrials.gov

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