MedTrace Logo

A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy

NCT05923866 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-04-01

No results posted yet for this study

Summary

This is a Phase 2, double-blind, parallel-group, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of multiple doses of ONO-2808 in patients with MSA. This is the first study of ONO-2808 in patients with MSA.

Conditions

  • Multiple System Atrophy (MSA)

Interventions

DRUG

ONO-2808

Oral administration of ONO-2808 at low, middle or high doses once a daily for 24 weeks in the core part and 80 weeks total including the extension part

DRUG

Placebo

Oral administration of placebo once a daily for 24 weeks in the core part and 32 weeks total including the extension part; Transition to low-dose of ONO-2808 for remainder of the extension part until week 80

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Project Leader · Ono Pharmaceutical Co. Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-09-22
Primary Completion
2025-09-15
Completion
2027-01-01
FDA Drug
Yes

Countries

  • United States
  • Japan

Study Locations

More Related Trials

Entities

Drugs

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 NCT05923866 on ClinicalTrials.gov