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.

Condition	Treatment or Intervention	Phase
Parkinson's Disease Multiple System Atrophy Orthostatic Hypotension	Drug: Fludrocortisone  Drug: Domperidone  Behavior: Conservative Measures for Orthostatic Hypotension	Phase I

Further Study Details: 

Primary Outcomes: Efficacy of conservative treatment, domperidone, and fludrocortisone for patient's subjective symptoms of orthostatic hypotension, and on objective autonomic testing
Expected Total Enrollment:  50

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.

Ages Eligible for Study:  40 Years   -   95 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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

K Schoffer, MD      3636-7675    schoffer@bigpond.net.au

Australia, Queensland
      Royal Brisbane and Women's Hospital, Brisbane,  Queensland,  4029,  Australia; Recruiting

Study ID Numbers:  2004/135; 2004/135
Record last reviewed:  February 2005
Last Updated:  February 14, 2005
Record first received:  February 11, 2005
ClinicalTrials.gov Identifier:  NCT00103597
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08