Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease (DEPOPA)

December 17, 2010 updated by: Johannes Gutenberg University Mainz

A Double Blind, Placebo Controlled, Randomized, Monocentre Cross-over Study to Investigate the Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease

This study will be conducted to study the effect of Desmopressin on the nocturnal micturition frequency in patients with idiopathic Parkinson syndrome.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, 55131
        • Klinikum der Johannes Gutenberg-Universität Mainz, Studienzentrum Neurologie, Langenbeckstr. 1, 55131 Mainz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male patients with idiopathic Parkinson Syndrome
  • 18 to 85 years
  • Nocturnal Pollakisuria > 2 mictions /night (documented in Screening phase )
  • Na+ i.S > 135 mmol/l
  • Patient is able to understand all aspects and individual consequences of the clinical trial
  • An informed consent signed and dated by the patient is available prior to any study specific treatment
  • The study is consistent with the patients´ request for an appropriate treatment

Exclusion Criteria:

  • Intake of the following concomitant medication: Carbamazepin, Oxcarbazepine, diuretics (Furosemide, Torasemide), non steroidal antiphlogistics, Loperamide, antidiuretic hormone analoga (besides study medication), drugs for treatment of bladder disfunction, in particular anticholinergics
  • Central Diabetes insipidus
  • Known heart insufficiency (NYHA Stad. III und IV)
  • clinical relevant kidney insufficiency
  • Habitual and psychogenic Polydipsia
  • Hypersensitivity or allergy against the trial medication or any other ingredient of the trial medication
  • Participation in another clinical trial during or within 6 months prior to this clinical trial
  • Medical or psychological condition, which might endanger the proper conduction of the clinical trial
  • Known drug or alcohol abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Desmopressin
Desmopressin 0,2 mg once daily and Desmopressin 0,2 mg bid for one week each.
Drug: Desmotabs
Desmotabs encapsulated, 0,2 mg once daily for one week, 0,2 mg bid for one week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
average nocturnal micturition frequency within the 2 weeks treatment phase each
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
safety and efficacy on nocturnal micturition frequency of Desmopressin in patients with Parkinson syndrome
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Investigators

  • Principal Investigator: Thomas Vogt, MD, Johannes Gutenberg University Mainz, Department of Neurology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

February 1, 2011

Study Registration Dates

First Submitted

December 9, 2008

First Submitted That Met QC Criteria

December 9, 2008

First Posted (Estimate)

December 10, 2008

Study Record Updates

Last Update Posted (Estimate)

December 20, 2010

Last Update Submitted That Met QC Criteria

December 17, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEPOPA-2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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