Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-30 @ 8:18 AM
Study NCT ID:
NCT01174459
Status:
COMPLETED
Last Update Posted:
2014-08-29
First Post:
2010-08-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012148', 'term': 'Restless Legs Syndrome'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'During the 12-month period or within 2 days after the last administration of pramipexole, up to 990 days.', 'description': 'Number of participants at risk is based on safety set.', 'eventGroups': [{'id': 'EG000', 'title': 'Patient With Restless Legs Syndrome', 'description': 'Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day', 'otherNumAtRisk': 510, 'otherNumAffected': 0, 'seriousNumAtRisk': 510, 'seriousNumAffected': 10}], 'seriousEvents': [{'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.1'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.1'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.1'}, {'term': 'Metastases to meninges', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.1'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.1'}, {'term': 'Impulse-control disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.1'}, {'term': 'Somatic hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Drug-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient With Restless Legs Syndrome', 'description': 'Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'Number of patients with drug-related adverse events', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set: all patients who were documented to have taken at least one dose of pramipexole except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '407', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient With Restless Legs Syndrome', 'description': 'Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.42', 'spread': '10.40', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 12 months or at the end of observation', 'description': 'International Restless Legs Syndrome rating scale (IRLS): The IRLS rating scale is a selfrating scale used to evaluate the severity of RLS and the patients are requested to answer 10 questions on a scale of 0 to 4. Respective scores (0-4 points) for the 10 questions were added up to calculate the total score on the IRLS. Therefore the total score is 0-40. The lower values represent a better outcome.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set: The patient set included all patients in the safety set with approved indication RLS and had IRLS total score measurement at baseline and at least one post-baseline time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patient With Restless Legs Syndrome', 'description': 'Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Registered patients', 'groupId': 'FG000', 'numSubjects': '571'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Case report form (CRF) collected', 'groupId': 'FG000', 'numSubjects': '566'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'case report form (CRF) not collected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patient With Restless Legs Syndrome', 'description': 'Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'spread': '16.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '298', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '212', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': "Safety set: all patients who were documented to have taken at least one dose of pramipexole except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact.\n\n56 patients who didn't visit hospital after the treatment of pramipexole for RLS were excluded from safety set."}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 571}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-28', 'studyFirstSubmitDate': '2010-08-02', 'resultsFirstSubmitDate': '2014-07-09', 'studyFirstSubmitQcDate': '2010-08-02', 'lastUpdatePostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-28', 'studyFirstPostDateStruct': {'date': '2010-08-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Drug-related Adverse Events', 'timeFrame': '12 Months', 'description': 'Number of patients with drug-related adverse events'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS)', 'timeFrame': 'after 12 months or at the end of observation', 'description': 'International Restless Legs Syndrome rating scale (IRLS): The IRLS rating scale is a selfrating scale used to evaluate the severity of RLS and the patients are requested to answer 10 questions on a scale of 0 to 4. Respective scores (0-4 points) for the 10 questions were added up to calculate the total score on the IRLS. Therefore the total score is 0-40. The lower values represent a better outcome.'}]}, 'conditionsModule': {'conditions': ['Restless Legs Syndrome']}, 'descriptionModule': {'briefSummary': 'The survey is conducted to investigate the safety and efficacy of long-term use of BI-Sifrol Tablets in Restless Legs Syndrome (RLS) patients with or without renal dysfunction in routine medical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '500', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nPatient with Restless Legs Syndrome\n\nExclusion criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT01174459', 'briefTitle': 'Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome', 'orgStudyIdInfo': {'id': '248.678'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with Restless Legs Syndrome'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Akashi', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 119', 'geoPoint': {'lat': 34.65524, 'lon': 135.00687}}, {'city': 'Akishima', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 52', 'geoPoint': {'lat': 35.72085, 'lon': 139.37999}}, {'city': 'Akita', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 16', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'city': 'Ami-machi', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 22'}, {'city': 'Asahi', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 36', 'geoPoint': {'lat': 35.71667, 'lon': 140.65}}, {'city': 'Asahikawa', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 1', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 40', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Chōfu', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 158', 'geoPoint': {'lat': 35.65924, 'lon': 139.54837}}, {'city': 'Chūō', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 78', 'geoPoint': {'lat': 35.67004, 'lon': 139.77544}}, {'city': 'Fujisawa', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 66', 'geoPoint': {'lat': 35.34926, 'lon': 139.47666}}, {'city': 'Fukagawa', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 7', 'geoPoint': {'lat': 43.70806, 'lon': 142.03917}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 144', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Boehringer Ingelheim 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'facility': 'Boehringer Ingelheim Investigational Site 74', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'city': 'Kanazawa', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 76', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'city': 'Katō', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 120', 'geoPoint': {'lat': 35.2285, 'lon': 139.89332}}, {'city': 'Kawai-machi', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 124'}, {'city': 'Kawasaki', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 60', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Kawasaki', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 63', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Keroyama-machi', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 31'}, {'city': 'Kitakyuushu', 'country': 'Japan', 'facility': 'Boehringer Ingelheim 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'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 80', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'city': 'Matsumoto', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 81', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'city': 'Matsuyama', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 142', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Mibu-machi', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 28'}, {'city': 'Miki-machi', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 138'}, {'city': 'Minoo', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 115', 'geoPoint': {'lat': 32.71667, 'lon': 129.86667}}, {'city': 'Mitaka', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 47', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}, {'city': 'Miyazaki', 'country': 'Japan', 'facility': 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'facility': 'Boehringer Ingelheim Investigational Site 148', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Nagoya', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 85', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nagoya', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 86', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nagoya', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 87', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nagoya', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 92', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nigata-honmachi', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 68', 'geoPoint': {'lat': 34.22364, 'lon': 132.65575}}, {'city': 'Nigata-honmachi', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site 69', 'geoPoint': {'lat': 34.22364, 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