Parkinson Disease
Conditions
Keywords
nycturia, Parkinson syndrome, desmopressin, Nocturnal polyuria in patients with Parkinson syndrome
Brief summary
This study will be conducted to study the effect of Desmopressin on the nocturnal micturition frequency in patients with idiopathic Parkinson syndrome.
Interventions
Desmotabs encapsulated, 0,2 mg once daily for one week, 0,2 mg bid for one week
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| average nocturnal micturition frequency within the 2 weeks treatment phase each | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| safety and efficacy on nocturnal micturition frequency of Desmopressin in patients with Parkinson syndrome | 8 weeks |
Countries
Germany