A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy

Parkinson's Disease Clinical Trial

Official title: A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy

Status Terminated

Clinical Trial Summary

Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients with symptomatic NOH.

Clinical Trial Description

This is a multi-center, multi-national, randomized, parallel-group, placebo-controlled, double-blind study with a 17 week (maximum) treatment period consisting of an initial, open-label dose titration (up to 2 weeks), followed by a washout period (up to 3 weeks), followed by a 12 week treatment period on a stable dose. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Dopamine Beta Hydroxylase Deficiency
• Hypotension
• Hypotension, Orthostatic
• Multiple System Atrophy
• Multiple Systems Atrophy
• Parkinson Disease
• Parkinson's Disease
• Pure Autonomic Failure
• Shy-Drager Syndrome
• Symptomatic Neurogenic Orthostatic Hypotension

• NCT number: NCT01927055
• Study type: Interventional
• Source: Chelsea Therapeutics
• Status: Terminated
• Phase: Phase 3
• Start date: November 2013
• Completion date: February 2015