NCT01927055

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Chelsea Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Symptomatic Neurogenic Orthostatic Hypotension
• Parkinson's Disease
• Multiple Systems Atrophy
• Pure Autonomic Failure
• Dopamine Beta Hydroxylase Deficiency

Interventions

Type	Name	Description
DRUG	Droxidopa	Droxidopa at 100 mg, 200 mg, 300 mg
DRUG	Placebo	Placebo to match droxidopa capsules and strength designations

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-08-22
• Last updated: 2016-01-08
• Results posted: 2016-01-08

Locations

3 sites across 1 country: United States