Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-01-01 @ 12:44 PM
Study NCT ID:
NCT00806468
Status:
TERMINATED
Last Update Posted:
2010-12-20
First Post:
2008-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D053158', 'term': 'Nocturia'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003894', 'term': 'Deamino Arginine Vasopressin'}], 'ancestors': [{'id': 'D001127', 'term': 'Arginine Vasopressin'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'lack of recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2011-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-17', 'studyFirstSubmitDate': '2008-12-09', 'studyFirstSubmitQcDate': '2008-12-09', 'lastUpdatePostDateStruct': {'date': '2010-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'average nocturnal micturition frequency within the 2 weeks treatment phase each', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'safety and efficacy on nocturnal micturition frequency of Desmopressin in patients with Parkinson syndrome', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nycturia', 'Parkinson syndrome', 'desmopressin', 'Nocturnal polyuria in patients with Parkinson syndrome'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to study the effect of Desmopressin on the nocturnal micturition frequency in patients with idiopathic Parkinson syndrome.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients with idiopathic Parkinson Syndrome\n* 18 to 85 years\n* Nocturnal Pollakisuria \\> 2 mictions /night (documented in Screening phase )\n* Na+ i.S \\> 135 mmol/l\n* Patient is able to understand all aspects and individual consequences of the clinical trial\n* An informed consent signed and dated by the patient is available prior to any study specific treatment\n* The study is consistent with the patients´ request for an appropriate treatment\n\nExclusion Criteria:\n\n* 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\n* Central Diabetes insipidus\n* Known heart insufficiency (NYHA Stad. III und IV)\n* clinical relevant kidney insufficiency\n* Habitual and psychogenic Polydipsia\n* Hypersensitivity or allergy against the trial medication or any other ingredient of the trial medication\n* Participation in another clinical trial during or within 6 months prior to this clinical trial\n* Medical or psychological condition, which might endanger the proper conduction of the clinical trial\n* Known drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT00806468', 'acronym': 'DEPOPA', 'briefTitle': 'Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'DEPOPA-2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desmopressin', 'description': 'Desmopressin 0,2 mg once daily and Desmopressin 0,2 mg bid for one week each.', 'interventionNames': ['Drug: Desmotabs']}], 'interventions': [{'name': 'Desmotabs', 'type': 'DRUG', 'description': 'Desmotabs encapsulated, 0,2 mg once daily for one week, 0,2 mg bid for one week', 'armGroupLabels': ['Desmopressin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Klinikum der Johannes Gutenberg-Universität Mainz, Studienzentrum Neurologie, Langenbeckstr. 1, 55131 Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'overallOfficials': [{'name': 'Thomas Vogt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johannes Gutenberg University Mainz, Department of Neurology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'PD Dr. Thomas Vogt', 'oldOrganization': 'Johannes Gutenberg University Mainz, Department of Neurology'}}}}