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

Part of paid clinical trials in La Jolla, California.

Sponsor
Teva Branded Pharmaceutical Products R&D LLC
Study ID
NCT06568237
Phase
PHASE2
Status
Recruiting
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Conditions

  • Multiple System Atrophy

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TEV-56286 — DRUG
    TEV-56286 capsules administered orally
  • Placebo — DRUG
    Matching placebo administered orally

Study Details

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 Dates

Start date
Oct 2, 2024
Status verified
Jun 2026
Primary completion
Sep 15, 2027
Completion
Sep 15, 2027

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TEV-56286
    Orally administered capsules once daily
  • Placebo Comparator: Placebo
    Orally administered capsules once daily

Primary Outcome Measure

For non-EU: Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (excluding item 11) [ Time Frame: Baseline to Week 48 ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Teva Investigational Site 15554La JollaCalifornia92037-
Teva Investigational Site 15545Los AngelesCalifornia90095-
Teva Investigational Site 15547Washington D.C.District of Columbia20007-
Teva Investigational Site 15544Boca RatonFlorida33486-
Teva Investigational Site 15555TampaFlorida33613-
Teva Investigational Site 15550ChicagoIllinois60612-3852-
Teva Investigational Site 15546Kansas CityKansas66160-
Teva Investigational Site 15736BostonMassachusetts02115-
Teva Investigational Site 15870Farmington HillsMichigan48334-
Teva Investigational Site 15552RochesterMinnesota55905-
Teva Investigational Site 15549New YorkNew York10016-
Teva Investigational Site 15551New YorkNew York10032-3726-
Teva Investigational Site 15553DurhamNorth Carolina27705-4410-
Teva Investigational Site 15735HersheyPennsylvania17033-
Teva Investigational Site 15548PittsburghPennsylvania15213-
Teva Investigational Site 15874NashvilleTennessee37212-
Teva Investigational Site 15869GeorgetownTexas78628-
Teva Investigational Site 15873AlexandriaVirginia22310-
Teva Investigational Site 15543SpokaneWashington99202-

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By research site
Teva Investigational· La Jolla, CATeva Investigational· Los Angeles, CATeva Investigational· Washington D.C., DCTeva Investigational· Boca Raton, FLTeva Investigational· Tampa, FLTeva Investigational· Chicago, IL

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