MedTrace Logo

Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy

NCT05696717 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-09-05

No results posted yet for this study

Summary

This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extension (LTE).

Conditions

  • Symptomatic Neurogenic Orthostatic Hypotension
  • MSA - Multiple System Atrophy

Interventions

DRUG

Ampreloxetine

Oral tablet, QD

DRUG

Placebo

Oral tablet, QD

Sponsors & Collaborators

  • Theravance Biopharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-27
Primary Completion
2026-01-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Brazil
  • Canada
  • Denmark
  • Estonia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • New Zealand
  • Poland
  • Portugal
  • Serbia
  • Spain
  • Taiwan
  • United Kingdom

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 NCT05696717 on ClinicalTrials.gov