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

This study has been terminated.
(lack of recruitment)
Sponsor:
Information provided by:
Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT00806468
First received: December 9, 2008
Last updated: December 17, 2010
Last verified: June 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Parkinson Disease
 Drug: Desmotabs
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • average nocturnal micturition frequency within the 2 weeks treatment phase each [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety and efficacy on nocturnal micturition frequency of Desmopressin in patients with Parkinson syndrome [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: February 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806468

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

No publications provided

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
Study First Received: December 9, 2008
Last Updated: December 17, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johannes Gutenberg University Mainz:
nycturia
Parkinson syndrome
desmopressin
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
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013