Double-blind, placebo controlled, randomised, monocenter cross-over studie to evaluate the effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome compared to placebo. - DEPOPA
- Conditions
- Effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson SyndromeMedDRA version: 9.1Level: LLTClassification code 10064016Term: Nocturnal polyuriaMedDRA version: 9.1Level: LLTClassification code 10061536Term: Parkinson's disease
- Registration Number
- EUCTR2008-003966-25-DE
- Lead Sponsor
- niversität Mainz, Klinik und Poliklinik für Neurologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 20
•Male patients with idiopathic Parkinson Syndrome
•18 bis 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 consistant with the patients´ request for an appropriate treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• forbidden concomitant medication (see protocol, chapter 4.2)
• central Diabetes insipidus
• Known heart insufficiency (NYHA Stad. III und IV)
• clinical relevant kidney insufficiency
• Habitual and psychogene 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 contuction of the clinical trial
• Known drug or alcohol abuse
• Intake of the following concomitant medication: Carbamazepin, Oxcarbazepin, diuretica (Furosemid, Torasemid), non steroidal antiphlogistics, Loperamid, antidiuretic hormone analoga (besides
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study the effect of Desmopressin on the nocturnal micturition frequency. ;Secondary Objective: - Effect of Desmopressin on:<br>time between intake of trial medication and the first nocturnal micturition,<br>quality of sleep and <br>quality of life<br>- Effect of dose strength of Desmopressin (0,2 mg und 0,4 mg) on the nocturnal micturition frequency<br>- To study the adverse events of Desmopressin, in particular a shift of electrolytes and to capture of a possible worsening of the Parkinson Syndrome<br>;Primary end point(s): average nocturnal micturition frequency during the 2-week treatment phase each per patient. It can be assumed that an antidiuretic effect occurs with the first dose of the trial drug
- Secondary Outcome Measures
Name Time Method