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

Study Overview
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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.

Official Title
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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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Desmotabs


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nycturia, Parkinson syndrome, desmopressin, Nocturnal polyuria in patients with Parkinson syndrome