Back to resultsEfficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System Atrophy
Primary Purpose
Parkinson's Disease, Multiple System Atrophy, Orthostatic Hypotension
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Fludrocortisone
Domperidone
Conservative Measures for Orthostatic Hypotension
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Orthostatic hypotension, Parkinson's Disease
Eligibility 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
Sites / Locations
- Royal Brisbane and Women's Hospital
Outcomes
Primary Outcome Measures
Efficacy of conservative treatment, domperidone, and fludrocortisone for patient's subjective symptoms of orthostatic hypotension, and on objective autonomic testing
Secondary Outcome Measures
Full Information
NCT ID
NCT00103597
First Posted
February 11, 2005
Last Updated
October 19, 2005
Sponsor
Royal Brisbane and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00103597
Brief Title
Efficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System Atrophy
Official Title
Efficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System Atrophy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Brisbane and Women's Hospital
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Multiple System Atrophy, Orthostatic Hypotension
Keywords
Orthostatic hypotension, Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fludrocortisone
Intervention Type
Drug
Intervention Name(s)
Domperidone
Intervention Type
Behavioral
Intervention Name(s)
Conservative Measures for Orthostatic Hypotension
Primary Outcome Measure Information:
Title
Efficacy of conservative treatment, domperidone, and fludrocortisone for patient's subjective symptoms of orthostatic hypotension, and on objective autonomic testing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerrie Schoffer, MBBS
Organizational Affiliation
Movement Disorders Fellow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
34000076
Citation
Veazie S, Peterson K, Ansari Y, Chung KA, Gibbons CH, Raj SR, Helfand M. Fludrocortisone for orthostatic hypotension. Cochrane Database Syst Rev. 2021 May 17;5(5):CD012868. doi: 10.1002/14651858.CD012868.pub2.
Results Reference
derived
Learn more about this trial
Efficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System Atrophy
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