Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-02 @ 9:36 AM
Study NCT ID:
NCT00263068
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2005-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome
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': 'C047508', 'term': 'rotigotine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 279}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-24', 'studyFirstSubmitDate': '2005-12-05', 'studyFirstSubmitQcDate': '2005-12-05', 'lastUpdatePostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability will be assessed by adverse events, changes in laboratory tests, changes in vital signs, physical and neurological examination, changes in menstrual and sexual function, global subject rating', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'To obtain data on changes in severity in RLS symptoms and quality of life over a one year maintenance period.', 'timeFrame': '1 year'}]}, 'conditionsModule': {'keywords': ['IDIOPATHIC RESTLESS LEGS SYNDROME'], 'conditions': ['Restless Legs Syndrome']}, 'descriptionModule': {'briefSummary': "This is a multicenter, open-label trial to assess safety and tolerability of rotigotine (SPM 936) in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year. Subjects who successfully completed the Maintenance Period and the Taper Period of SP792 are allowed to enroll in this trial.\n\nAll subjects will begin the Titration Period at a daily dosage of 1.125mg rotigotine (2.5cm2 patch). Subjects will be up-titrated at 7-day intervals in 1.125mg (2.5cm2 increments, initial titration step only) and 2.25mg intervals (5cm2) increments to a maximum dose of 6.75mg/day (15cm2) rotigotine. The maximum length of titration is 28 days (±3 days), although not all subjects will require 28 days to reach their optimal dose.\n\nA subject's dose may be increased or decreased, as needed by the investigator to maintain a subject's effective dose during the Maintenance Period. A Taper Period is provided to allow for safe, gradual withdrawal from trial medication"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Idiopathic restless legs syndrome\n\nExclusion Criteria:\n\n* Subject has an ongoing serious adverse event from SP792 that is assessed to be related to the trial medication by the investigator and/or the sponsor.\n* Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, 2 years postmenopausal, or does not consistently use 2 combined effective methods of contraception, including at least 1 barrier method, unless sexually abstinent.\n* Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this trial."}, 'identificationModule': {'nctId': 'NCT00263068', 'briefTitle': 'An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'An Open-Label Extension Trial to Investigate the Safety and Tolerability of Long-Term Treatment With Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome', 'orgStudyIdInfo': {'id': 'SP0793'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Up to 6.75 mg/day (optimal dosing)', 'interventionNames': ['Drug: Rotigotine']}], 'interventions': [{'name': 'Rotigotine', 'type': 'DRUG', 'description': 'Transdermal Patch 1 per day for 24 hours containing:\n\n1.125mg/day 2.25mg/day 4.5mg/day 6.75mg/day', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'RTP', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Schwarz'}], 'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'UCB'}}}}