NCT05696717

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

A Phase 3, Multi-center, Randomized Withdrawal and Long Term Extension Study of Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Participants With Multiple System Atrophy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Ampreloxetine	Oral tablet, QD
DRUG	Placebo	Oral tablet, QD

Timeline

• Start date: 2023-06-27
• Primary completion: 2026-01-01
• Completion: 2028-01-01
• First posted: 2023-01-25
• Last updated: 2025-09-05

Locations

79 sites across 20 countries: United States, Argentina, Australia, Austria, Brazil, Canada, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Portugal, Serbia, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study