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

This study has been completed.
Sponsor:
Information provided by:
Royal Brisbane and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00103597
First received: February 11, 2005
Last updated: October 19, 2005
Last verified: July 2005
History of Changes
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Multiple System Atrophy
Orthostatic Hypotension
 Drug: Fludrocortisone
Drug: Domperidone
Behavioral: Conservative Measures for Orthostatic Hypotension
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System Atrophy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Royal Brisbane and Women's Hospital:

Primary Outcome Measures:
  • Efficacy of conservative treatment, domperidone, and fludrocortisone for patient's subjective symptoms of orthostatic hypotension, and on objective autonomic testing

Estimated Enrollment: 50
Study Start Date: January 2005
Estimated Study Completion Date: September 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103597

Locations
Australia, Queensland
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
Sponsors and Collaborators
Royal Brisbane and Women's Hospital
Investigators
Principal Investigator: Kerrie Schoffer, MBBS Movement Disorders Fellow
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00103597     History of Changes
Other Study ID Numbers: 2004/135, 2004/135
Study First Received: February 11, 2005
Last Updated: October 19, 2005
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Royal Brisbane and Women's Hospital:
Orthostatic hypotension
Parkinson's Disease

Additional relevant MeSH terms:
Hypotension
Hypotension, Orthostatic
Parkinson Disease
Multiple System Atrophy
Shy-Drager Syndrome
Atrophy
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pathological Conditions, Anatomical
Domperidone
Fludrocortisone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists

ClinicalTrials.gov processed this record on May 16, 2013