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Clinical Trial Summary

A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH over 182 weeks.


Clinical Trial Description

This is a Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH. The study consists of 3 periods: (i) 26-week treatment, (ii) 156-week treatment extension, and (iii) 2-week follow-up. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04095793
Study type Interventional
Source Theravance Biopharma
Contact
Status Terminated
Phase Phase 3
Start date September 19, 2019
Completion date November 12, 2021

See also
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Completed NCT03750552 - Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure Phase 3
Terminated NCT03829657 - Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure Phase 3
Completed NCT02586623 - Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension Phase 4