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

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.

Timeline

Start

2019-01-24

Primary completion

2021-07-21

Completion

2021-07-21

Outcome

Missed primary endpoint

registry analysis (superiority test); Ampreloxetine vs Placebo; p = 0.574; Least Squares Mean Difference -0.23 (95% CI -1.05 to 0.58) NCT03750552 ↗

Drugs

Indications