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

February 11, 2005
October 19, 2005
January 2005
Not Provided
Efficacy of conservative treatment, domperidone, and fludrocortisone for patient's subjective symptoms of orthostatic hypotension, and on objective autonomic testing
Same as current
Complete list of historical versions of study NCT00103597 on ClinicalTrials.gov Archive Site
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Efficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System Atrophy
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Parkinson's Disease
  • Multiple System Atrophy
  • Orthostatic Hypotension
  • Drug: Fludrocortisone
  • Drug: Domperidone
  • Behavioral: Conservative Measures for Orthostatic Hypotension
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2005
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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
Both
40 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00103597
2004/135, 2004/135
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Royal Brisbane and Women's Hospital
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Principal Investigator: Kerrie Schoffer, MBBS Movement Disorders Fellow
Royal Brisbane and Women's Hospital
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP