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

Primary Purpose

Parkinson Disease

Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Desmotabs
Sponsored by
Johannes Gutenberg University Mainz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring nycturia, Parkinson syndrome, desmopressin, Nocturnal polyuria in patients with Parkinson syndrome

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Desmopressin

Arm Description

Desmopressin 0,2 mg once daily and Desmopressin 0,2 mg bid for one week each.

Outcomes

Primary Outcome Measures

average nocturnal micturition frequency within the 2 weeks treatment phase each

Secondary Outcome Measures

safety and efficacy on nocturnal micturition frequency of Desmopressin in patients with Parkinson syndrome

Full Information

First Posted
December 9, 2008
Last Updated
December 17, 2010
Sponsor
Johannes Gutenberg University Mainz
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1. Study Identification

Unique Protocol Identification Number
NCT00806468
Brief Title
Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease
Acronym
DEPOPA
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 Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
February 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Johannes Gutenberg University Mainz

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
nycturia, Parkinson syndrome, desmopressin, Nocturnal polyuria in patients with Parkinson syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desmopressin
Arm Type
Experimental
Arm Description
Desmopressin 0,2 mg once daily and Desmopressin 0,2 mg bid for one week each.
Intervention Type
Drug
Intervention Name(s)
Desmotabs
Intervention Description
Desmotabs encapsulated, 0,2 mg once daily for one week, 0,2 mg bid for one week
Primary Outcome Measure Information:
Title
average nocturnal micturition frequency within the 2 weeks treatment phase each
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
safety and efficacy on nocturnal micturition frequency of Desmopressin in patients with Parkinson syndrome
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Vogt, MD
Organizational Affiliation
Johannes Gutenberg University Mainz, Department of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum der Johannes Gutenberg-Universität Mainz, Studienzentrum Neurologie, Langenbeckstr. 1, 55131 Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany

12. IPD Sharing Statement

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

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