At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 195 enrolled
Drug / intervention
ampreloxetine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating ampreloxetine and Placebo for Symptomatic Neurogenic Orthostatic Hypotension. Completed, enrolled 195 participants across 125 sites in 19 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Bulgaria, Canada, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Portugal, Russia, Spain, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartJan 2019
Primary CompletionJul 2021
TodayJul 2026
First PostedNov 23, 2018
Enrollment StartJan 24, 2019
Primary CompletionJul 21, 2021
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.6 years ago
Interventions
ampreloxetinedrug
Oral tablet, QD
Placebodrug
Oral tablet, QD