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

This study has been completed.

Sponsor:

Information provided by:

Royal Brisbane and Women's Hospital

ClinicalTrials.gov Identifier:

NCT00103597

First received: February 11, 2005

Last updated: October 19, 2005

Last verified: July 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

February 11, 2005

Last Updated Date

October 19, 2005

Start Date ^ICMJE

January 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00103597 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Parkinson's Disease
Multiple System Atrophy
Orthostatic Hypotension

Intervention ^ICMJE

Drug: Fludrocortisone
Drug: Domperidone
Behavioral: Conservative Measures for Orthostatic Hypotension

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 95 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT00103597

Other Study ID Numbers ^ICMJE

2004/135, 2004/135

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Royal Brisbane and Women's Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kerrie Schoffer, MBBS

Movement Disorders Fellow

Information Provided By

Royal Brisbane and Women's Hospital

Verification Date

July 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top