Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease
Phase 4
Terminated
- Conditions
- Parkinson Disease
- Interventions
- Drug: Desmotabs
- Registration Number
- NCT00806468
- Lead Sponsor
- Johannes Gutenberg University Mainz
- Brief Summary
This study will be conducted to study the effect of Desmopressin on the nocturnal micturition frequency in patients with idiopathic Parkinson syndrome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 1
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Desmopressin Desmotabs Desmopressin 0,2 mg once daily and Desmopressin 0,2 mg bid for one week each.
- Primary Outcome Measures
Name Time Method average nocturnal micturition frequency within the 2 weeks treatment phase each 6 weeks
- Secondary Outcome Measures
Name Time Method safety and efficacy on nocturnal micturition frequency of Desmopressin in patients with Parkinson syndrome 8 weeks
Trial Locations
- Locations (1)
Klinikum der Johannes Gutenberg-Universität Mainz, Studienzentrum Neurologie, Langenbeckstr. 1, 55131 Mainz
🇩🇪Mainz, Germany