NCT00806468

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_4 parkinson-disease

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

December 20, 2010

Status Verified

June 1, 2010

Enrollment Period

1.8 years

First QC Date

December 9, 2008

Last Update Submit

December 17, 2010

Conditions

Parkinson Disease

Keywords

nycturiaParkinson syndromedesmopressinNocturnal polyuria in patients with Parkinson syndrome

Outcome Measures

Primary Outcomes (1)

  • average nocturnal micturition frequency within the 2 weeks treatment phase each

    6 weeks

Secondary Outcomes (1)

  • safety and efficacy on nocturnal micturition frequency of Desmopressin in patients with Parkinson syndrome

    8 weeks

Study Arms (1)

Desmopressin

EXPERIMENTAL

Desmopressin 0,2 mg once daily and Desmopressin 0,2 mg bid for one week each.

Drug: Desmotabs

Interventions

DesmotabsDRUG

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

Desmopressin

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients with idiopathic Parkinson Syndrome
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum der Johannes Gutenberg-Universität Mainz, Studienzentrum Neurologie, Langenbeckstr. 1, 55131 Mainz

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Parkinson DiseaseNocturia

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arginine VasopressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Thomas Vogt, MD

    Johannes Gutenberg University Mainz, Department of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 9, 2008

First Posted

December 10, 2008

Study Start

February 1, 2009

Primary Completion

December 1, 2010

Study Completion

February 1, 2011

Last Updated

December 20, 2010

Record last verified: 2010-06

Locations

DE(1)