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A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
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)
Who can join
Ages 30 to 75 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- TEV-56286 (drug)
- Placebo (drug)
Sponsor: Teva Branded Pharmaceutical Products R&D LLC · Participants: 350 · Started: Oct 2, 2024
Contact the study team
- Teva U.S. Medical Information · Phone: 1-888-483-8279
Official record on ClinicalTrials.gov — NCT06568237
Locations in the U.S.
| California | Teva Investigational Site 15554, La Jolla Teva Investigational Site 15545, Los Angeles (Not yet recruiting) |
| District of Columbia | Teva Investigational Site 15547, Washington D.C. |
| Florida | Teva Investigational Site 15555, Tampa |
| Illinois | Teva Investigational Site 15550, Chicago |
| Kansas | Teva Investigational Site 15546, Kansas City |
| Massachusetts | Teva Investigational Site 15736, Boston |
| Michigan | Teva Investigational Site 15870, Farmington Hills (Not yet recruiting) |
| Minnesota | Teva Investigational Site 15552, Rochester |
| New York | Teva Investigational Site 15549, New York Teva Investigational Site 15551, New York |
| Pennsylvania | Teva Investigational Site 15735, Hershey (Not yet recruiting) Teva Investigational Site 15548, Pittsburgh |
| Tennessee | Teva Investigational Site 15874, Nashville |
| Texas | Teva Investigational Site 15869, Georgetown (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.