Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-03-20 @ 5:22 AM
Study NCT ID:
NCT00627003
Status:
COMPLETED
Last Update Posted:
2011-04-25
First Post:
2008-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077465', 'term': 'Cabergoline'}], 'ancestors': [{'id': 'D004873', 'term': 'Ergolines'}, {'id': 'D004876', 'term': 'Ergot Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-22', 'studyFirstSubmitDate': '2008-02-19', 'studyFirstSubmitQcDate': '2008-02-19', 'lastUpdatePostDateStruct': {'date': '2011-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep efficiency', 'timeFrame': 'Week 5'}, {'measure': 'PLMS-arousal index (PLMS-AI)', 'timeFrame': 'Week 5'}], 'secondaryOutcomes': [{'measure': 'Sleep Questionnaire Form A', 'timeFrame': 'Weeks 2 and 5'}, {'measure': 'Quality of Life for RLS questionnaire', 'timeFrame': 'Weeks 2 and 5'}, {'measure': 'Clinical Global Impressions', 'timeFrame': 'Weeks 2 and 5'}, {'measure': 'Safety including type and frequency of adverse events, changes in laboratory data and abnormalities observed in electrocardiography', 'timeFrame': 'Weeks 2 and 5'}, {'measure': 'Total score of the severity rating scale of the International RLS (IRLS) Study Group', 'timeFrame': 'Weeks 2 and 5'}, {'measure': 'RLS-6 severity scales', 'timeFrame': 'Weeks 2 and 5'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Restless Legs Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=CABAS-0067-033&StudyName=A%20study%20to%20evaluate%20the%20efficacy%20and%20safety%20of%20cabergoline%20compared%20with%20placebo%20for%20the%20treatment%20of%20RLS%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with placebo on periodic leg movements (PLMS) arousl index and sleep efficiency in patients with RLS. Also, additional objective and subjective sleep parameters and quality of life will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Idiopathic RLS\n* Moderate to severe symptoms as indicated by an IRLS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4\n* In a baseline polysomnography, patients had to have periodic leg movements during sleep arousal index greater than 5/hour of total sleep time\n\nExclusion Criteria:\n\n* Patients suffering from seconadry RLS, due to causes such as iron deficiency or renal disease, or suffering from secondary RLS while taking drugs suspected of causing secondary forms of RLS'}, 'identificationModule': {'nctId': 'NCT00627003', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled Multicenter Efficacy Study for the Treatment of Patients With Restless Legs Syndrome (RLS)', 'orgStudyIdInfo': {'id': 'CABAS-0067-033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Cabergoline']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Cabergoline', 'type': 'DRUG', 'description': 'Cabergoline oral tablets administered once daily in the evening: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14, followed by a stable dose for an additional 3 weeks', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo oral tablets administered daily for 5 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}