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

NCT ID: NCT00806468

Last Updated: 2010-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-02-28

Brief Summary

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

Detailed Description

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Conditions

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Parkinson Disease

Keywords

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nycturia Parkinson syndrome desmopressin Nocturnal polyuria in patients with Parkinson syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Desmopressin

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

Group Type EXPERIMENTAL

Desmotabs

Intervention Type DRUG

Desmotabs encapsulated, 0,2 mg once daily for one week, 0,2 mg bid for one week

Interventions

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Desmotabs

Desmotabs encapsulated, 0,2 mg once daily for one week, 0,2 mg bid for one week

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Johannes Gutenberg University Mainz, Department of Neurology

Principal Investigators

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Thomas Vogt, MD

Role: PRINCIPAL_INVESTIGATOR

Johannes Gutenberg University Mainz, Department of Neurology

Locations

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

Mainz, , Germany

Site Status

Countries

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Germany

Other Identifiers

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DEPOPA-2008

Identifier Type: -

Identifier Source: org_study_id