Back to Results

RESTORE


Title A clinical study of patients with symptomatic neurogenic orthostatic hypotension to assess sustained effects of droxidopa therapy
Therapeutic Area Low Blood Pressure, Neurogenic Orthostatic Hypotension
Principal Investigator Bryan Ho, MD
Min Age 18 Years
Gender All
Contact Sarah Gans
617-636-7606

Overview

This is a 36 week. multi-site, placebo-controlled, double-blind, randomized withdrawal, time to intervention of droxidopa study in adult patients with symptomatic NOH associated with primary autonomic failure including Parkinson’s Disease (PD), Multiple System Atrophy (MSA), or Pre Autonomic Failure (PAF), or Non-diabetic autonomic Neuropathy (NDAN) or dopamine beta hydroxylase (NBH) deficiency. The primary objective is to evaluate the time to treatment intervention.  The secondary objective is to determine the long-term efficacy of droxidopa in this patient population. 

Study Details

Inclusion Criteria

  • Ability to stand with or without limited assistance.
  • Clinical diagnostis of symptomatic NOH associated with Primary Autonomic Failure (PD, MSA or PAF) or NDAN or DBH Deficiency
  • Patients currently taking droxidopa are eligible, but it is not required.

Exclusion Criteria

  • Women who are breastfeeding or pregnant.
  • Sustained supine hypertension greater than or equal to 180mmHg systolic or 110mmHg diastolic.
  • Treatment of hypertension with antidypertensive medications.

Study Requirements

Number of research visits: 8

Length of participation:36 weeks

Number of blood collections: 2

Must be able to check blood pressure at home.  A blood pressure cuff will be provided if needed.