{"protocolSection":{"identificationModule":{"nctId":"NCT00621517","orgStudyIdInfo":{"id":"ETSU-07-061f"},"organization":{"fullName":"East Tennessee State University","class":"OTHER"},"briefTitle":"Bupropion and Restless Legs Syndrome","officialTitle":"Bupropion and Restless Legs Syndrome"},"statusModule":{"statusVerifiedDate":"2019-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-02"},"primaryCompletionDateStruct":{"date":"2009-07","type":"ACTUAL"},"completionDateStruct":{"date":"2009-07","type":"ACTUAL"},"studyFirstSubmitDate":"2008-02-12","studyFirstSubmitQcDate":"2008-02-21","studyFirstPostDateStruct":{"date":"2008-02-22","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-03-04","resultsFirstSubmitQcDate":"2012-04-04","resultsFirstPostDateStruct":{"date":"2012-04-05","type":"ESTIMATED"},"lastUpdateSubmitDate":"2019-02-14","lastUpdatePostDateStruct":{"date":"2019-03-06","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Max Bayard","investigatorTitle":"Associate Professor of Family Medicine","investigatorAffiliation":"East Tennessee State University"},"leadSponsor":{"name":"East Tennessee State University","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to determine if bupropion will improve the symptoms of restless legs syndrome (RLS).","detailedDescription":"Adult patients with moderate to severe RLS will be recruited for the study. Those on medications which treat RLS will be asked to discontinue the medications for two weeks prior to beginning the study. All participants will be screened with Beck Depression Inventory, International Restless Legs Syndrome Study Group (IRLSSG) severity scale, and Clinical Global Impression of Improvement (CGI-I) scale. An ordinal scale (i.e. rate symptoms from 1-8) will also be obtained. Participants will be randomized to a placebo or medication group. Those in the medication group will be given 150 mg of bupropion at night for six weeks. Others will receive similar-appearing placebo. Participants will be called at the end of weeks one, two, four and five to assess symptom severity based on IRLSSG scale, and to determine if they are experiencing any adverse effects. At three weeks and six weeks, participants will return to the clinic to complete all four of the initial forms, the Beck Depression Inventory, IRLSSG severity scale, ordinal scale, and CGI-I."},"conditionsModule":{"conditions":["Restless Legs Syndrome"],"keywords":["Restless Legs Syndrome","Bupropion"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2","PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":60,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1","type":"EXPERIMENTAL","description":"Participants will receive 150MG Bupropion nightly.","interventionNames":["Drug: Bupropion"]},{"label":"2","type":"PLACEBO_COMPARATOR","description":"Participants will receive matching placebo capsule nightly.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Bupropion","description":"Partipants will receive 150 mg bupropion per night","armGroupLabels":["1"],"otherNames":["Wellbutrin"]},{"type":"DRUG","name":"Placebo","description":"1 capsule nightly for six weeks","armGroupLabels":["2"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale.","description":"Scale ranges from 0 to 40 points with higher scores being associated with more severe symptoms of restless legs syndrome. There are 10 questions, with points of 0 to 4 per question. The change in IRLSSG score from baseline is recorded at three and six weeks.","timeFrame":"Baseline, three weeks, and six weeks"},{"measure":"Clinical Global Impression - Improvement Scale","timeFrame":"three weeks and six weeks"},{"measure":"Ordinal Scale (i.e., 1-8) of Symptom Severity","timeFrame":"three weeks and six weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* clinical diagnosis of Restless Legs Syndrome\n* Severity Scale score 15 or higher\n\nExclusion Criteria:\n\n* History of seizures\n* History of alcohol use greater than 2 drinks per day or occasional binges of 5 or more drinks per day\n* Suicidal thoughts/ideations\n* Inability to return for follow up appointments at 3 and 6 weeks\n* Lack of access to telephone\n* Eating disorder\n* Age less than 18\n* Pregnancy\n* Unwillingness or inability to discontinue any RLS medications","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"East Tennessee State University","city":"Johnson City","state":"Tennessee","zip":"37614","country":"United States","geoPoint":{"lat":36.31344,"lon":-82.35347}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Bupropion","description":"Participants will receive 150MG Bupropion nightly."},{"id":"FG001","title":"Placebo","description":"Participants will receive matching placebo capsule nightly."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"31"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"24"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"7"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Bupropion","description":"Participants will receive 150MG Bupropion nightly."},{"id":"BG001","title":"Placebo","description":"Participants will receive matching placebo capsule nightly."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"60"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"52"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"8"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"48.0","spread":"12.9"},{"groupId":"BG001","value":"50.5","spread":"14.1"},{"groupId":"BG002","value":"49.3","spread":"13.5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"46"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"14"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"60"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale.","description":"Scale ranges from 0 to 40 points with higher scores being associated with more severe symptoms of restless legs syndrome. There are 10 questions, with points of 0 to 4 per question. The change in IRLSSG score from baseline is recorded at three and six weeks.","populationDescription":"Intention to Treat","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"points on a scale","timeFrame":"Baseline, three weeks, and six weeks","groups":[{"id":"OG000","title":"Bupropion","description":"Participants will receive 150MG Bupropion nightly."},{"id":"OG001","title":"Placebo","description":"Participants will receive matching placebo capsule nightly."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"31"}]}],"classes":[{"title":"Change in IRLSSG score from baseline to 6 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-10.4","spread":"10.1"},{"groupId":"OG001","value":"-7.6","spread":"7.1"}]}]},{"title":"Change in IRLSSG score from baseline to 3 weeks","categories":[{"measurements":[{"groupId":"OG000","value":"-10.8","spread":"10.0"},{"groupId":"OG001","value":"-6.0","spread":"6.6"}]}]}]},{"type":"PRIMARY","title":"Clinical Global Impression - Improvement Scale","populationDescription":"Once we started recruiting patients, we had decided not to do this outcome so this data was not obtained.","reportingStatus":"POSTED","timeFrame":"three weeks and six weeks","groups":[{"id":"OG000","title":"Bupropion","description":"Participants will receive 150MG Bupropion nightly."},{"id":"OG001","title":"Placebo","description":"Participants will receive matching placebo capsule nightly."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"PRIMARY","title":"Ordinal Scale (i.e., 1-8) of Symptom Severity","populationDescription":"Once we started recruiting patients, we had decided not to do this outcome so this data was not obtained.","reportingStatus":"POSTED","timeFrame":"three weeks and six weeks","groups":[{"id":"OG000","title":"Bupropion","description":"Participants will receive 150MG Bupropion nightly."},{"id":"OG001","title":"Placebo","description":"Participants will receive matching placebo capsule nightly."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Bupropion","description":"Participants will receive 150MG Bupropion nightly.","seriousNumAffected":1,"seriousNumAtRisk":29,"otherNumAffected":1,"otherNumAtRisk":29},{"id":"EG001","title":"Placebo","description":"Participants will receive matching placebo capsule nightly.","seriousNumAffected":0,"seriousNumAtRisk":31,"otherNumAffected":2,"otherNumAtRisk":31}],"seriousEvents":[{"term":"miscarriage","organSystem":"Pregnancy, puerperium and perinatal conditions","notes":"Pregnancy was an exclusion criterion; participant denied pregnancy initially. Following this event, criteria to avoid possibility of similar event were added.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":24}]}],"otherEvents":[{"term":"nausea","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":31}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Possible Type II error as we were unable to recruit our target of 100 participants."},"certainAgreement":{"piSponsorEmployee":true,"restrictiveAgreement":false},"pointOfContact":{"title":"Max Bayard MD","organization":"East Tennessee State University","email":"mmbayard3@gmail.com","phone":"802-524-8805"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"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":"D016642","term":"Bupropion"}],"ancestors":[{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}