RecruitingPhase 2ACTRN12609000080224

Desmopressin for the Treatment of Orthostatic Hypotension and Excessive Nighttime Urination in Parkinson’s Disease

A Double-Blind, Placebo-controlled Crossover Clinical Trial of Desmopressin for the Treatment of Orthostatic Hypotension and Nocturia in Parkinson’s Disease


Sponsor

John O'Sullivan

Enrollment

20 participants

Start Date

Apr 6, 2009

Study Type

Interventional

Conditions

Summary

We plan to study 20 patients with idiopathic Parkinson's disease with complications of orthostatic hypotension and nocturia. In an 8 week double-blinded, crossover study design, we will study the effects of oral desmopressin (or matching placebo) on orthostatic hypotension, nocturia, and sleep.


Eligibility

Sex: Both males and femalesMin Age: 30 YearssMax Age: 85 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for people with Parkinson's disease who also have two specific problems: low blood pressure when they stand up (orthostatic hypotension), which can cause dizziness or fainting, and needing to urinate two or more times during the night (nocturia). Researchers are testing whether a medicine called desmopressin, taken by mouth, can help with both of these problems. The study runs for 8 weeks, and participants will take either the real medicine or a matching placebo (dummy pill) during different parts of the study, so everyone gets to try both. You may be eligible if: - You are between 30 and 85 years old - You have been diagnosed with Parkinson's disease - You experience low blood pressure when you stand up - You need to empty your bladder 2 or more times each night You may NOT be eligible if: - You have a history of kidney failure, congestive heart failure, or liver cirrhosis - You have a history of low blood sodium (hyponatremia) - You have dementia Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Subjects will start with either nightly placebo or oral desmopressin for three weeks. After a washout period of one week of no medication, they will then switch to the therapy they have not tried for

Subjects will start with either nightly placebo or oral desmopressin for three weeks. After a washout period of one week of no medication, they will then switch to the therapy they have not tried for another three weeks. Subjects taking desmopressin will begin with a 100 mcg nightly dose. If this is tolerated, after one week they will increase to 200 mcg nightly, which they will take for two weeks.


Locations(1)

Australia

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ACTRN12609000080224


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