Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT02231294
Status:
COMPLETED
Last Update Posted:
2014-09-04
First Post:
2014-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Sifrol® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077487', 'term': 'Pramipexole'}], 'ancestors': [{'id': 'D052160', 'term': 'Benzothiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1464}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-02', 'studyFirstSubmitDate': '2014-09-02', 'studyFirstSubmitQcDate': '2014-09-02', 'lastUpdatePostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Parkinson signs and symptoms by means of a 4-point rating scale', 'timeFrame': 'up to 6 weeks'}, {'measure': 'Occurrence of tremor (rest and postural) by means of a 4-point rating scale', 'timeFrame': 'up to 6 weeks', 'description': "Short Parkinson's Evaluation Scale (SPES)"}, {'measure': 'Change in severity of kinetic tremor assessed by tremor spiral test', 'timeFrame': 'up to 6 weeks'}, {'measure': 'Occurrence of depression by means of a 4-point SPES rating scale', 'timeFrame': 'up to 6 weeks'}, {'measure': 'Change in severity of depression by means of an 8-point rating scale', 'timeFrame': 'up to 6 weeks', 'description': 'Clinical Global Impression (CGI) rating scale'}, {'measure': 'Self-Assessment of depression by patient by means of six different visual analogue scales (VAS)', 'timeFrame': 'up to 6 weeks', 'description': 'VAS (10 cm)'}, {'measure': 'Assessment of efficacy by investigator on a 5-point rating scale', 'timeFrame': 'after 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of patients with adverse drug reactions', 'timeFrame': 'up to 6 weeks'}, {'measure': 'Assessment of tolerability by investigator on a 5-point scale', 'timeFrame': 'after 6 weeks'}, {'measure': 'Assessment of tolerability by patient on a 5-point scale', 'timeFrame': 'after 6 weeks'}]}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Documentation of the effect of SIFROL® on tremor and depression as well as its tolerability in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Ambulatory patients with idiopathic parkinson's disease requiring therapy with Sifrol®", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with idiopathic Parkinson's disease with tremor and/or depression requiring therapy with Sifrol® or change of therapy to Sifro®l and not under medication with neuroleptics were allowed to be observed during the study\n\nExclusion Criteria:\n\n* Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SPC) for Sifrol®\n* Patients under treatment with neuroleptics should not be observed during this study"}, 'identificationModule': {'nctId': 'NCT02231294', 'briefTitle': "The Effect of Sifrol® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': "The Effect of SIFROL® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease Patients.", 'orgStudyIdInfo': {'id': '248.511'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Idiopathic Parkinson's Disease Patients", 'interventionNames': ['Drug: Sifrol®']}], 'interventions': [{'name': 'Sifrol®', 'type': 'DRUG', 'armGroupLabels': ["Idiopathic Parkinson's Disease Patients"]}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}