E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064016 |
E.1.2 | Term | Nocturnal polyuria |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061536 |
E.1.2 | Term | Parkinson's disease |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To study the effect of Desmopressin on the nocturnal micturition frequency. |
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E.2.2 | Secondary objectives of the trial |
- 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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |