drugset / Trial / NCT05696717
Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ampreloxetine | Small molecule | — | Oral |