Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT00806468
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00806468
Study Brief:
Protocol Section:
NCT00806468