Trial record 5 of 7 for: "Pure Autonomic Failure" | "Droxidopa"
A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01927055|
Recruitment Status : Terminated (Due to potential competition with a post-marketing study requested by FDA)
First Posted : August 22, 2013
Results First Posted : January 8, 2016
Last Update Posted : January 8, 2016
Information provided by (Responsible Party):
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment|
Symptomatic Neurogenic Orthostatic Hypotension
Multiple Systems Atrophy
Pure Autonomic Failure
Dopamine Beta Hydroxylase Deficiency
|Recruitment Details||61 patients enrolled in the open-label dose titration, 16 patients discontinued in the open-label period and 45 patients continued on to the randomized double-blind treatment period.|
The study was prematurely terminated; the limited sample size precludes meaningful conclusions on the efficacy or safety of droxidopa in this study.