NCT02586623

Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 453 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the time to treatment intervention in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) Deficiency who have been previously stabilized with droxidopa therapy for symptoms of neurogenic orthostatic hypotension (NOH) (dizziness, light-headedness, or feelings that they are about to black out)

Detailed description

This is a multi-site, placebo-controlled, double-blind, randomized withdrawal, time to intervention study with a duration of up to 36 weeks, consisting of 5 periods: Screening Period: up to 4 weeks duration; Open-Label Titration Period (Titration Period): up to 4 weeks duration; Open-Label Treatment Period (Open-Label Period): 12 weeks duration; Double-Blind Treatment Period (Double-Blind Period): 12 weeks duration; Safety Follow-Up Period: 4 weeks duration

Conditions

• Symptomatic Neurogenic Orthostatic Hypotension

Interventions

Type	Name	Description
DRUG	Droxidopa capsules	100, 200 or 300 mg
DRUG	Placebo capsules

Timeline

• Start date: 2016-02-11
• Primary completion: 2022-07-21
• Completion: 2022-09-09
• First posted: 2015-10-26
• Last updated: 2023-08-23
• Results posted: 2023-08-23

Locations

168 sites across 1 country: United States