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CompletedNCT00103597Updated Oct 20, 2005

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

A Phase 1 interventional study of Fludrocortisone and Domperidone in Parkinson's Disease, Multiple System Atrophy and Orthostatic Hypotension, sponsored by Royal Brisbane and Women's Hospital. Completed at 1 site in Australia. Open to participants aged 40 Years to 95 Years. Per ClinicalTrials.gov, last updated 2005-10-20.

Sponsored by Royal Brisbane and Women's Hospital · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
40 Years to 95 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parkinson's Disease
  • Multiple System Atrophy
  • Orthostatic Hypotension

Keywords

  • Orthostatic hypotension
  • Parkinson's Disease
03

Who can participate

Ages eligible
40 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
50 participants

Interventions

  • DrugFludrocortisone
  • DrugDomperidone
  • BehavioralConservative Measures for Orthostatic Hypotension
05

What researchers measure

Primary outcomes

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

06

Study locations

1 site
  • Royal Brisbane and Women's Hospital
    Brisbane, Queensland 4029, Australia
07

References and documents

Publications

  • 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. PubMed 34000076 ↗
08

Registry details

Key details

Study ID
NCT00103597
Lead sponsor
Royal Brisbane and Women's Hospital
First posted
Feb 14, 2005
Start date
Jan 2005
Completion
Sep 2005
Last update
Oct 20, 2005

Study contacts

Kerrie Schoffer, MBBS
principal investigator · Movement Disorders Fellow
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2005. You cannot join it, but the record below documents what was studied.

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