NCT04095793

Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure

A Phase 3, 182-week, Open-Label, Extension Study to Investigate the Safety and Tolerability of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension (Symptomatic nOH) in Subjects With Primary Autonomic Failure

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Symptomatic Neurogenic Orthostatic Hypotension

Interventions

Type	Name	Description
DRUG	ampreloxetine	Oral tablet, QD

Timeline

• Start date: 2019-09-19
• Primary completion: 2021-11-12
• Completion: 2021-11-12
• First posted: 2019-09-19
• Last updated: 2022-11-30
• Results posted: 2022-11-30

Locations

55 sites across 18 countries: United States, Australia, Austria, Bulgaria, Canada, Denmark, Estonia, France, Germany, Israel, Italy, New Zealand, Poland, Portugal, Russia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study