A Study to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy (MSA): A Safety and Efficacy Study
NCT ID: NCT06568237
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2024-10-02
2027-06-17
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TEV-56286
Orally administered capsules once daily
TEV-56286
TEV-56286 capsules administered orally
Placebo
Orally administered capsules once daily
Placebo
Matching placebo administered orally
Interventions
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TEV-56286
TEV-56286 capsules administered orally
Placebo
Matching placebo administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 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
30 Years
75 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Tev Medical Expert, Study Director
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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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 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 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
Padua, , 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
Countries
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Central Contacts
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Related Links
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TOPAS-MSA Web Site
Teva MSA Trial EU Locations
Other Identifiers
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2023-505320-54-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
TV56286-NDG-20039
Identifier Type: -
Identifier Source: org_study_id