A Phase 3 Multi-center Randomized Withdrawal and Long-Term Extension Study of Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Participants with Multiple System Atrophy

Brief description of study

To evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH compared with placebo as measured by the OHSA composite score over a double-blind, RW period of 8 weeks following an OL period of 12 weeks. This study includes 4 periods: Screening, OL, RW, and Long-Term Treatment Extension (LTE). Screening is approximately 14 days. The OL and RW periods of the study are a Phase 3, multi-center, RW study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. Approximately 102 participants will be enrolled such that at least 72 participants continue into the RW period. The LTE period is to evaluate the safety and tolerability of ampreloxetine in participants with MSA and symptomatic nOH over 104 weeks.


Clinical Study Identifier: s23-00335
ClinicalTrials.gov Identifier: NCT05696717
Principal Investigator: Patricio Alejandro Millar Vernetti.
Other Investigator: Daniel Rebolledo Garcia.


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