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| Sponsored by: |
Royal Brisbane and Women's Hospital |
|---|---|
| Information provided by: | Royal Brisbane and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00103597 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease Multiple System Atrophy Orthostatic Hypotension |
Drug: Fludrocortisone Drug: Domperidone Behavioral: Conservative Measures for Orthostatic Hypotension |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Uncontrolled, Crossover Assignment, Efficacy Study |
| Official Title: | Efficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System Atrophy |
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | September 2005 |
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.
Eligibility| Ages Eligible for Study: | 40 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Australia, Queensland | |
| Royal Brisbane and Women's Hospital | |
| Brisbane, Queensland, Australia, 4029 | |
| Principal Investigator: | Kerrie Schoffer, MBBS | Movement Disorders Fellow |
More Information
| Study ID Numbers: | 2004/135, 2004/135 |
| Study First Received: | February 11, 2005 |
| Last Updated: | October 19, 2005 |
| ClinicalTrials.gov Identifier: | NCT00103597 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
Orthostatic hypotension Parkinson's Disease |
|
Multiple system atrophy Pathological Conditions, Anatomical Hypotension Hypotension, Orthostatic Ganglion Cysts Basal Ganglia Diseases Vascular Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases |
Dopamine Domperidone Postural hypotension Multiple System Atrophy Parkinson Disease Movement Disorders Fludrocortisone Atrophy Parkinsonian Disorders |
|
Anti-Inflammatory Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Gastrointestinal Agents Antiemetics Dopamine Antagonists |
Pharmacologic Actions Autonomic Agents Therapeutic Uses Cardiovascular Diseases Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |
