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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00103597
• Other study ID #: 2004/135
• Secondary ID: 2004/135
• Status: Completed
• Phase: Phase 1
• First received: February 11, 2005
• Last updated: October 19, 2005
• Start date: January 2005
• Est. completion date: September 2005

Study information

• Verified date: July 2005
• Source: Royal Brisbane and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophy
• Hypotension
• Hypotension, Orthostatic
• Multiple System Atrophy
• Orthostatic Hypotension
• Parkinson Disease
• Parkinson's Disease
• Shy-Drager Syndrome

Intervention

Drug:
• Fludrocortisone

• Domperidone

Behavioral:
• Conservative Measures for Orthostatic Hypotension

Locations

Country	Name	City	State
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brisbane and Women's Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of conservative treatment, domperidone, and fludrocortisone for patient's subjective symptoms of orthostatic hypotension, and on objective autonomic testing