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Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease

A Double Blind, Placebo Controlled, Randomized, Monocentre Cross-over Study to Investigate the Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00806468
Acronym
DEPOPA
Enrollment
1
Registered
2008-12-10
Start date
2009-02-28
Completion date
2011-02-28
Last updated
2010-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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

DRUGDesmotabs

Desmotabs encapsulated, 0,2 mg once daily for one week, 0,2 mg bid for one week

Sponsors

Johannes Gutenberg University Mainz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No

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

MeasureTime frame
average nocturnal micturition frequency within the 2 weeks treatment phase each6 weeks

Secondary

MeasureTime frame
safety and efficacy on nocturnal micturition frequency of Desmopressin in patients with Parkinson syndrome8 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026