Effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome MedDRA version: 9.1 Level: LLT Classification code 10064016 Term: Nocturnal polyuria MedDRA version: 9.1 Level: LLT Classification code 10061536 Term: Parkinson's disease
Conditions
Interventions
Trade Name: Desmotabs® 0,2 mg Tabletten
Product Name: Desmotabs® 0,2mg Tabletten
Pharmaceutical Form: Capsule*
INN or Proposed INN: Desmopressin Acetat
Concentration unit: mg milligram(s)
Concentratio
Sponsors
Universität Mainz, Klinik und Poliklinik für Neurologie
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: •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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effect of Desmopressin on the nocturnal micturition frequency. ;Secondary Objective: - Effect of Desmopressin on: time between intake of trial medication and the first nocturnal micturition, quality of sleep and quality of life - Effect of dose strength of Desmopressin (0,2 mg und 0,4 mg) on the nocturnal micturition frequency - To study the adverse events of Desmopressin, in particular a shift of electrolytes and to capture of a possible worsening of the Parkinson Syndrome ;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 | — |
Countries
Germany
Outcome results
None listed