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

NCT06568237 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

TEV-56286

TEV-56286 capsules administered orally

DRUG

Placebo

Matching placebo administered orally

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D LLC

    lead INDUSTRY

Principal Investigators

  • Tev Medical Expert, Study Director · Teva Branded Pharmaceutical Products R&D LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-02
Primary Completion
2027-09-15
Completion
2027-09-15
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06568237 on ClinicalTrials.gov