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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Parkinson's Disease, Multiple System Atrophy, Orthostatic Hypotension

Intervention / Treatment
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* Drug: Fludrocortisone
* Drug: Domperidone
* Behavioral: Conservative Measures for Orthostatic Hypotension


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fludrocortisone|nan|
|Drug: Domperidone|nan|
|Behavioral: Conservative Measures for Orthostatic Hypotension|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of conservative treatment, domperidone, and fludrocortisone for patient's subjective symptoms of orthostatic hypotension, and on objective autonomic testing |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthostatic hypotension, Parkinson's Disease