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A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
Sponsor: Teva Branded Pharmaceutical Products R&D LLC
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.
Official title: 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)
Key Details
Gender
All
Age Range
30 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2024-10-02
Completion Date
2027-09-15
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
TEV-56286
TEV-56286 capsules administered orally
Placebo
Matching placebo administered orally
Locations (54)
Teva Investigational Site 15554
La Jolla, California, United States
Teva Investigational Site 15545
Los Angeles, California, United States
Teva Investigational Site 15547
Washington D.C., District of Columbia, United States
Teva Investigational Site 15544
Boca Raton, Florida, United States
Teva Investigational Site 15555
Tampa, Florida, United States
Teva Investigational Site 15550
Chicago, Illinois, United States
Teva Investigational Site 15546
Kansas City, Kansas, United States
Teva Investigational Site 15736
Boston, Massachusetts, United States
Teva Investigational Site 15870
Farmington Hills, Michigan, United States
Teva Investigational Site 15552
Rochester, Minnesota, United States
Teva Investigational Site 15549
New York, New York, United States
Teva Investigational Site 15551
New York, New York, United States
Teva Investigational Site 15553
Durham, North Carolina, United States
Teva Investigational Site 15735
Hershey, Pennsylvania, United States
Teva Investigational Site 15548
Pittsburgh, Pennsylvania, United States
Teva Investigational Site 15869
Georgetown, Texas, United States
Teva Investigational Site 15873
Alexandria, Virginia, United States
Teva Investigational Site 15543
Spokane, Washington, United States
Teva Investigational Site 35290
Bordeaux, France
Teva Investigational Site 35289
Marseille, France
Teva Investigational Site 35291
Salpêtrière, France
Teva Investigational Site 35292
Toulouse, France
Teva Investigational Site 32823
Beelitz-Heilstätten, Germany
Teva Investigational Site 32818
Dresden, Germany
Teva Investigational Site 32822
Düsseldorf, Germany
Teva Investigational Site 32825
Kassel, Germany
Teva Investigational Site 32826
Leipzig, Germany
Teva Investigational Site 32824
Marburg, Germany
Teva Investigational Site 32820
München, Germany
Teva Investigational Site 32819
Münster, Germany
Teva Investigational Site 32821
Ulm, Germany
Teva Investigational Site 80203
Haifa, Israel
Teva Investigational Site 80215
Jerusalem, Israel
Teva Investigational Site 80204
Tel Aviv, Israel
Teva Investigational Site 30299
Bologna, Italy
Teva Investigational Site 30297
Catania, Italy
Teva Investigational Site 30298
Milan, Italy
Teva Investigational Site 30294
Padova, Italy
Teva Investigational Site 30296
Roma, Italy
Teva Investigational Site 30295
Salerno, Italy
Teva Investigational Site 84140
Chiba, Japan
Teva Investigational Site 84139
Fuchū, Japan
Teva Investigational Site 84136
Gifu, Japan
Teva Investigational Site 84137
Niigata, Japan
Teva Investigational Site 84138
Sagamihara, Japan
Teva Investigational Site 84141
Sanda-shi, Japan
Teva Investigational Site 84135
Sendai, Japan
Teva Investigational Site 31323
Barcelona, Spain
Teva Investigational Site 31321
Barcelona, Spain
Teva Investigational Site 31324
Barcelona, Spain
Teva Investigational Site 31327
Madrid, Spain
Teva Investigational Site 31320
Pamplona, Spain
Teva Investigational Site 31322
Seville, Spain
Teva Investigational Site 31319
Valencia, Spain