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

NCT00103597 | Completed Phase 1

• 1 other identifier: 2004/135
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Multiple System Atrophy; Orthostatic Hypotension

Keywords

Orthostatic hypotension; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

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

Interventions

Fludrocortisone DRUG

Domperidone DRUG

Conservative Measures for Orthostatic Hypotension BEHAVIORAL

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Brisbane and Women's Hospital: lead

Study Sites (1)

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Related Publications (1)

• 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.

  PMID: 34000076 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy; Hypotension, Orthostatic

Interventions

Fludrocortisone; Domperidone

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Orthostatic Intolerance; Hypotension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hydrocortisone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kerrie Schoffer, MBBS

  Movement Disorders Fellow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 11, 2005
• First Posted: February 14, 2005
• Study Start: January 1, 2005
• Study Completion: September 1, 2005
• Last Updated: October 20, 2005

Record last verified: 2005-07

Locations

AU (1)