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

NCT ID: NCT00103597

Last Updated: 2005-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-09-30

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.

Conditions

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Parkinson's Disease Multiple System Atrophy Orthostatic Hypotension

Keywords

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Orthostatic hypotension Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Fludrocortisone

Intervention Type DRUG

Domperidone

Intervention Type DRUG

Conservative Measures for Orthostatic Hypotension

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Brisbane and Women's Hospital

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Kerrie Schoffer, MBBS

Role: PRINCIPAL_INVESTIGATOR

Movement Disorders Fellow

Locations

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Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 34000076 (View on PubMed)

Other Identifiers

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2004/135

Identifier Type: -

Identifier Source: secondary_id

2004/135

Identifier Type: -

Identifier Source: org_study_id