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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00103597

Enrollment

Registered

2005-02-14

Start date

2005-01-31

Completion date

2005-09-30

Last updated

2005-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple System Atrophy, Orthostatic Hypotension, Parkinson's Disease

Keywords

Orthostatic hypotension, Parkinson's Disease

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.

Interventions

DRUGFludrocortisone

DRUGDomperidone

BEHAVIORALConservative Measures for Orthostatic Hypotension

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to 95 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Efficacy of conservative treatment, domperidone, and fludrocortisone for patient's subjective symptoms of orthostatic hypotension, and on objective autonomic testing	—

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026