Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure

Summary

A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure

Timeline

Start

2019-02-22

Primary completion

2021-11-10

Completion

2021-11-10

Outcome

Missed primary endpoint

Stopped: “Stopped early due to company decision. Company decision based on analysis results in TD-9855-0169.”

registry analysis (superiority test); RW Treatment Period: Placebo vs RW Treatment Period: Ampreloxetine; p = 0.196; Odds Ratio (OR) 0.60 (95% CI 0.27 to 1.29); Regression, Logistic NCT03829657 ↗

release “The primary endpoint was not statistically significant for the overall population of patients” theravance.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ampreloxetine	Small molecule	—	Oral

Indications