NCT03750552

Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure

A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

A Phase 3 study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH with up to 4 weeks of treatment.

Detailed description

A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH. The study consists of 3 periods: (i) 4-week screening, (ii) 4-week randomized treatment, and (iii) 2-week follow up. The trial utilizes an operational design featuring the ability to conduct protocol required visits as either in clinic or remote visits (except Screening visit).

Conditions

• Symptomatic Neurogenic Orthostatic Hypotension

Interventions

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

Timeline

• Start date: 2019-01-24
• Primary completion: 2021-07-21
• Completion: 2021-07-21
• First posted: 2018-11-23
• Last updated: 2022-09-14
• Results posted: 2022-09-14

Locations

125 sites across 19 countries: United States, Australia, Austria, Bulgaria, Canada, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Portugal, Russia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study