[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657501":3},{"organization":4,"outcomesModule":7,"designInfo":67,"detailedDescription":74,"studyPopulation":66,"armGroups":75,"interventions":82,"overallOfficials":66,"centralContacts":88,"locations":98,"responsibleParty":172,"collaborators":66,"id":174,"slug":175,"hasResults":176,"nctId":177,"briefTitle":178,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":176,"sex":181,"minAge":182,"maxAge":66,"enrollmentInfo":183,"targetDuration":66,"studyType":186,"phases":187,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":119,"whyStopped":66,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},{"fullName":5,"class":6},"Navamedic AB","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":66},[9],{"measure":10,"description":11,"timeFrame":12},"Patient acceptability and satisfaction with the OraFID dosing device, self-reported via questionnaire","Assessed using a patient-reported questionnaire evaluating acceptability, ease of use, and satisfaction with the OraFID dosing device.","12 weeks",[14,17,20,23,26,29,31,34,38,41,44,47,49,51,54,57,60,63],{"measure":15,"description":16,"timeFrame":12},"User opinion, usage, and ability to use the Levilog app","Self-reported via questionnaire on app usage and usability",{"measure":18,"description":19,"timeFrame":12},"Time required per dispensation\u002Ftreatment with the OraFID device","Self-reported via questionnaire regarding the device",{"measure":21,"description":22,"timeFrame":12},"Compliance with the dosing schedule","Data obtained from the Levilog app and drug accountability records",{"measure":24,"description":25,"timeFrame":12},"Compliance with the app, i.e., willingness to register doses","Compliance and treatment data from Levilog app use, combined with self-reported data",{"measure":27,"description":28,"timeFrame":12},"Safety and acceptability of Flexilev delivered by OraFID and the app","Assessed via adverse event and serious adverse event reporting, and study withdrawals",{"measure":30,"description":19,"timeFrame":12},"Overall acceptability of Flexilev\u002FOraFID\u002FApp",{"measure":32,"description":33,"timeFrame":12},"User opinion of Flexilev treatment","Self-reported via questionnaire regarding treatment",{"measure":35,"description":36,"timeFrame":37},"Change in non-motor symptoms","Non-Motor Symptoms Questionnaire (NMSQ), self-reported","Baseline to week 12",{"measure":39,"description":40,"timeFrame":37},"Change in depression symptoms","Hospital Anxiety and Depression Scale (HADS-D), self-reported",{"measure":42,"description":43,"timeFrame":37},"Change in quality of life","Parkinson's Disease Questionnaire (PDQ-8) and EQ-5D-5L (including VAS), self-reported",{"measure":45,"description":46,"timeFrame":37},"Change in symptom variation (On-Off phenomena)","Self-reported OnOff Scale questionnaire",{"measure":48,"description":46,"timeFrame":37},"Change in average daily normalized \"off\" time",{"measure":50,"description":46,"timeFrame":37},"Change in average daily normalized \"on\" time without troublesome dyskinesia",{"measure":52,"description":53,"timeFrame":37},"Change in sleep quality","Parkinson's Disease Sleep Scale (PDSS-2), self-reported",{"measure":55,"description":56,"timeFrame":12},"Motor function in daily life","Unified Parkinson's Disease Rating Scale (UPDRS), physician-reported",{"measure":58,"description":59,"timeFrame":37},"Change in motor function (UPDRS Parts II and III)","Movement Disorder Society - Unified Parkinson's Disease Rating Scale (UPDRS), physician-reported",{"measure":61,"description":62,"timeFrame":37},"Change in disease severity","Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD), physician-reported",{"measure":64,"description":65,"timeFrame":37},"Change in symptoms, treatment effects, and overall quality","Patient-Reported Outcomes in Parkinson's Disease (PRO-PD), self-reported",null,{"allocation":68,"interventionModel":69,"interventionModelDescription":70,"primaryPurpose":71,"observationalModel":66,"timePerspective":66,"maskingInfo":72},"NA","SINGLE_GROUP","Single group of participants receives Flexilev\u002FOraFID\u002FApp treatment; no comparator arm.","DEVICE_FEASIBILITY",{"masking":73,"maskingDescription":66,"whoMasked":66},"NONE","This is an open-label, observational, up to 12-week study evaluating patients' experience with Flexilev minitablets delivered through the OraFID dosing device and the Levilog reminder app.\n\nParticipants first complete an up-to-two-week run-in period, during which their current treatment is recorded and eligibility is assessed. Eligible patients then switch to Flexilev delivered by OraFID, are trained on the device and app, and receive an individualized dosing schedule based on their doctor's evaluation and prior treatment. Other daytime levodopa medications are stopped during the study, though slow-release levodopa is allowed at night; levodopa infusions are not permitted.\n\nWithin a week of starting treatment, patients receive a follow-up phone call to confirm or adjust the dosing schedule and check for any safety or device\u002Fapp issues. This is followed by a 12-week treatment period, with phone check-ins at weeks 4 and 8 and an in-person visit at week 12. Dose adjustments are permitted throughout the study if needed.",[76],{"label":77,"type":78,"description":79,"interventionNames":80},"Flexilev with OraFID and App","EXPERIMENTAL","Participants receive individualized Flexilev (levodopa\u002Fcarbidopa) minitablet treatment delivered via the OraFID dosing device, with an optional Levilog reminder app to support dosing compliance, over a 12-week treatment period.",[81],"Device: OraFID dosing device, Levodopa\u002FCarbidopa minitablets delivered via OraFID dosing device",[83],{"type":84,"name":85,"description":86,"armGroupLabels":87,"otherNames":66},"DEVICE","OraFID dosing device, Levodopa\u002FCarbidopa minitablets delivered via OraFID dosing device","Intervention Description\n\nLevodopa 5 mg\u002Fcarbidopa 1.25 mg dispersible minitablets, individually dosed in 5 mg levodopa increments (1-20 tablets per dose) via the OraFID mechanical dispensing device, with an optional Levilog app for dosing reminders and adherence tracking.",[77],[89,94],{"name":90,"role":91,"phone":92,"phoneExt":66,"email":93},"Dag Nyholm, Professor","CONTACT","0046186115003","dag.nyholm@uu.se",{"name":95,"role":91,"phone":96,"phoneExt":66,"email":97},"Jack Spira, MD. Ph.D.","0046722506272","jack.spira@navamedic.com",[99,117,133,147,161],{"facility":100,"status":101,"city":102,"state":103,"zip":66,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":112},"Karolinska University Hospital","NOT_YET_RECRUITING","Stockholm","Stockholm County","Sweden","SE",{"type":107,"coordinates":108},"Point",[109,110],18.06871,59.32938,{"lat":110,"lon":109},[113],{"name":114,"role":91,"phone":115,"phoneExt":66,"email":116},"Anders Johansson, MD, PhD","0046812373424","anders.c.johansson@regionstockholm.se",{"facility":118,"status":119,"city":120,"state":121,"zip":122,"country":104,"countryCode":105,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Uppsala University Hospital","RECRUITING","Uppsala","Uppsala County","751 85",{"type":107,"coordinates":124},[125,126],17.63889,59.85882,{"lat":126,"lon":125},[129,130],{"name":90,"role":91,"phone":92,"phoneExt":66,"email":93},{"name":131,"role":132,"phone":66,"phoneExt":66,"email":66},"Davide Paonessa, MD","SUB_INVESTIGATOR",{"facility":134,"status":101,"city":135,"state":66,"zip":136,"country":104,"countryCode":105,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Sahlgrenska universitetssjukhuset","Gothenburg","413 45",{"type":107,"coordinates":138},[139,140],11.96679,57.70716,{"lat":140,"lon":139},[143],{"name":144,"role":91,"phone":145,"phoneExt":66,"email":146},"Filip Bergquist, Professor","0046317863425","filip.bergquist@gu.se",{"facility":148,"status":119,"city":149,"state":66,"zip":150,"country":104,"countryCode":105,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Skane University Hospital","Lund","222 42",{"type":107,"coordinates":152},[153,154],13.19321,55.70584,{"lat":154,"lon":153},[157],{"name":158,"role":91,"phone":159,"phoneExt":66,"email":160},"Per Odiin, Professor","004646175649","per.odin@med.lu.se",{"facility":162,"status":101,"city":102,"state":66,"zip":163,"country":104,"countryCode":105,"cosmosGeoPoint":164,"geoPoint":166,"contacts":167},"Centrum för Neurologi","113 65",{"type":107,"coordinates":165},[109,110],{"lat":110,"lon":109},[168],{"name":169,"role":91,"phone":170,"phoneExt":66,"email":171},"Per Svenningsson, MD, PhD. Professor","004682379990","per.svenningsson@regionstockholm.se",{"type":173,"investigatorFullName":66,"investigatorTitle":66,"investigatorAffiliation":66,"oldNameTitle":66,"oldOrganization":66},"SPONSOR","100657501","phase-4-a-12-week-study-of-flexilev-with-the-orafid-device-and-app-in-parkinsons-patients-100657501",false,"NCT07839793","A 12-Week Study of Flexilev With the OraFID Device and App in Parkinson's Patients","FLORA","Inclusion Criteria:\n\n* Male or female subjects, 30 years of age or older at the time of screening, with a diagnosis of idiopathic PD that is levodopa-responsive\n* Have a minimum of 4 levodopa dosing occasions per day\n* Stable medication within the last 4 weeks\n* Be judged by the investigator to be eligible for Flexilev treatment.\n* Subject (or caregiver, if applicable) demonstrates the understanding and correct use of the OraFID delivery system, as assessed by the investigator or designee.\n* Subject (or caretaker on behalf of the subject) is willing to use Patients Own Reporting module in the Parkinson registry and is willing to answer all questionnaires.\n* Have a smartphone (either patient or caregiver)\n* Ability to consent and comply with study specific procedures\n* Able to read and write in Swedish\n\nExclusion Criteria:\n\n* Inability of subject or caregiver to use the device\n* Female patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for three months later.\n* Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception.","ALL","30 Years",{"count":184,"type":185},58,"ESTIMATED","INTERVENTIONAL",[188],"PHASE4","Flexilev is a Parkinson's disease medicine made of small, dissolvable tablets containing low doses of levodopa and carbidopa, allowing doses to be adjusted in small, precise steps. OraFID is a new mechanical device that dispenses the exact number of tablets needed, with better than 99% accuracy, in amounts from 1 to 20 tablets. An optional companion app, Levilog, reminds patients when to take their dose and records how much medicine (tablets and milligrams) was taken.\n\nThis 12-week study will mainly assess how acceptable this treatment routine is and how well patients stick with it when using Flexilev with the OraFID device and app. It will also evaluate the treatment's efficacy, safety, and tolerability.",[191],"PARKINSON DISEASE (Disorder)",[193],"Parkinson's Disease, Levodopa, Carbidopa, Flexilev, OraFID, Precision dosing, Individualized dosing, Dose titration, Minitablets","2026-09-18",{"date":196,"type":197},"2026-09-24","ACTUAL",{"date":199,"type":197},"2026-05-25",{"date":201,"type":185},"2027-06-30",{"name":5,"class":6},5]