Skip to main content
OpenTrials
Completed

NCT Number: NCT00103597

Efficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System Atrophy

Patients with Parkinson's Disease or Multiple System Atrophy (MSA), and symptoms of orthostatic hypotension, are eligible for the study. Each patient will have three weeks of conservative therapy, three weeks of therapy with fludrocortisone, and three weeks of therapy with domperidone. Autonomic testing, a symptom questionnaire, bedside blood pressure testing, and Unified Parkinson Disease Rating Scale (UPDRS) will be performed after each intervention.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson's Disease Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Hypotension Hypotension, Orthostatic Movement Disorders Multiple System Atrophy Nervous System Diseases Neurodegenerative Diseases Orthostatic Hypotension Orthostatic Intolerance Parkinson Disease Parkinsonian Disorders Primary Dysautonomias Synucleinopathies Vascular Diseases

Age range

40 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

About this study

Enrolled patients, ages 40-95, must have Parkinson's or MSA, diagnosed by a neurologist, and symptoms of orthostatic hypotension. Each patient will fill out two validated questionnaires to determine if they are candidates for the study. Baseline patient details, such as their medications and UPDRS, will be recorded. Medications must be held stable during the period of the study.

Each patient will then have three weeks of conservative therapy, three weeks of therapy with fludrocortisone, and three weeks of therapy with domperidone. Autonomic testing, a symptom questionnaire, bedside blood pressure testing, and UPDRS will be performed after each intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients residing in Queensland Australia
  • Age 40-95
  • Parkinson's Disease or MSA diagnosed by a neurologist
  • Symptoms of orthostatic hypotension, as defined by 2 validated questionnaires

Exclusion criteria

  • Patients with acute cardiomyopathy or cardiac condition
  • Patients unable to give consent
  • Patients not stable on their Parkinsonian medications
  • Patients with another cause for autonomic neuropathy

Treatment and study plan

fludrocortisone

Drug

Domperidone

Drug

Conservative Measures for Orthostatic Hypotension

Behavioral

Primary outcomes

  1. Efficacy of conservative treatment, domperidone, and fludrocortisone for patient's subjective symptoms of orthostatic hypotension, and on objective autonomic testing

Sponsors and collaborators

Lead sponsor

Royal Brisbane and Women's Hospital

Other Gov

Registry information

Important dates

Study start
2005
Study completion
2005
First posted
Feb 14, 2005
Registry last updated
Oct 20, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.