drugset / Trial / NCT05696717

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

NCT05696717

Phase 3 Active not recruiting 102 enrolled Theravance Biopharma
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2023-06-27
Primary completion
2026-01
Completion
2028-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator ampreloxetine Small molecule Oral