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Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03750552
Study type Interventional
Source Theravance Biopharma
Contact
Status Completed
Phase Phase 3
Start date January 24, 2019
Completion date July 21, 2021

See also
  Status Clinical Trial Phase
Terminated NCT04095793 - Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure Phase 3
Terminated NCT01927055 - A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy Phase 3
Recruiting NCT05696717 - Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy Phase 3
Completed NCT01149629 - Study of the Fed-Fast Pharmocokinetics and Bioequivalance of 300mg Capsules of Droxidopa Phase 1
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