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

Parkinson Disease Clinical Trial

— DEPOPA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00806468
• Other study ID #: DEPOPA-2008
• Status: Terminated
• Phase: Phase 4
• First received: December 9, 2008
• Last updated: December 17, 2010
• Start date: February 2009
• Est. completion date: February 2011

Study information

• Verified date: June 2010
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This study will be conducted to study the effect of Desmopressin on the nocturnal micturition frequency in patients with idiopathic Parkinson syndrome.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Germany	Klinikum der Johannes Gutenberg-Universität Mainz, Studienzentrum Neurologie, Langenbeckstr. 1, 55131 Mainz	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average nocturnal micturition frequency within the 2 weeks treatment phase each		6 weeks	No
Secondary	safety and efficacy on nocturnal micturition frequency of Desmopressin in patients with Parkinson syndrome		8 weeks	Yes