We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00806468
Recruitment Status : Terminated (lack of recruitment)
First Posted : December 10, 2008
Last Update Posted : December 20, 2010
Information provided by:
Johannes Gutenberg University Mainz

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Desmotabs Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. average nocturnal micturition frequency within the 2 weeks treatment phase each [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. safety and efficacy on nocturnal micturition frequency of Desmopressin in patients with Parkinson syndrome [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806468

Klinikum der Johannes Gutenberg-Universität Mainz, Studienzentrum Neurologie, Langenbeckstr. 1, 55131 Mainz
Mainz, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Principal Investigator: Thomas Vogt, MD Johannes Gutenberg University Mainz, Department of Neurology

Responsible Party: PD Dr. Thomas Vogt, Johannes Gutenberg University Mainz, Department of Neurology
ClinicalTrials.gov Identifier: NCT00806468     History of Changes
Other Study ID Numbers: DEPOPA-2008
First Posted: December 10, 2008    Key Record Dates
Last Update Posted: December 20, 2010
Last Verified: June 2010

Keywords provided by Johannes Gutenberg University Mainz:
Parkinson syndrome
Nocturnal polyuria in patients with Parkinson syndrome

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Deamino Arginine Vasopressin
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs