[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594123":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":38,"locations":43,"responsibleParty":45,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":43,"enrollmentInfo":61,"targetDuration":43,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":78,"whyStopped":43,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":43},{"fullName":5,"class":6},"Eva Pharma","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Test: Rotigexole 8 mg\u002F24 hours transdermal patch","EXPERIMENTAL","At the beginning of the intervention phase, patients' randomization will take place to determine the sequence of reference (R) and test (T) administration to either RTRT group or TRTR group. After obtaining all baseline characteristics, once daily patch application of one patch of 8 mg\u002F24 h of Test (T) or Reference (R) over 4 days, i.e. a total of 4 alternating applications with RT sequence or TR sequence will be administered. Each patch remains applied for 24 h and the treatment patches may be directly switched without washout phase.",[13],"Drug: Rotigexole 8 mg",{"label":15,"type":16,"description":11,"interventionNames":17},"Reference: Neupro® 8 mg\u002F 24 hours transdermal patch","ACTIVE_COMPARATOR",[18],"Drug: Neupro ® 8 mg",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Rotigexole 8 mg","Rotigotine 8 mg",[9],[23],{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":29},"Neupro ® 8 mg",[15],[23],[31,35],{"name":32,"affiliation":33,"role":34},"Hatem S Mohammed, Dr.","Al-Manial Specialized Hospital - Cairo University","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Ali S Shalash, Dr.","Ain Shams Specialized Hospital - Ain Shams University",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Lydia Bahig","CONTACT","01225952401",null,"lydia.bahig@marc-eg.org",{"type":46,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[48],{"name":49,"class":50},"MARC-CRO","UNKNOWN","100594123","adhesion-and-safety-of-rotigexole-compared-to-neupro-100594123",false,"NCT07015346","Adhesion and Safety of Rotigexole Compared to Neupro®","A Non-inferiority Open-labelled Crossover Randomized Controlled Trial, of Two Arms, to Investigate the Adhesiveness and Safety of Rotigexole 8 mg\u002F24 Hours Transdermal Patch, Manufactured by Eva Pharma, Egypt, Compared to the Innovator Product, Neupro® 8 mg\u002F 24 Hours Transdermal Patch, Manufactured by UCB Pharma S.A., Belgium, After 24 Hours of Application","START","Inclusion Criteria:\n\n1. Male or Female patients aged ≥30 years at Screening\n2. Diagnosed with idiopathic Parkinson's disease with a Hoehn and Yahr stage of II to III.\n3. Patients who have not received dopamine agonists in the past 30 days or are willing to discontinue current dopamine agonist therapy for the duration of the study\n4. Subjects should have a Mini Mental State Examination (MMSE) score of ≥25 at Screening.\n5. Participants who are able to tolerate Rotigotine transdermal patch incremental run-in period for 3 weeks.\n6. Willing to refrain from swimming, bathing or sauna use on assessment days.\n7. Participants should be using a reliable method of contraception (e.g., intrauterine device, barrier methods, condoms) throughout the study and for at least 30 days after the last dose of study medication\n8. Female participants should have a negative pregnancy test at screening, before starting study medication and for at least 30 days after the last dose of study medication\n9. Ability to provide written informed consent.\n\nExclusion Criteria:\n\n1. Patients with a medical history indicating a Parkinsonian syndrome other than idiopathic PD (e.g., drug-induced, post-stroke)\n2. History of significant skin hypersensitivity to adhesives or other transdermal products.\n3. History of or clinical features consistent with atypical parkinsonian syndromes (e.g., multiple system atrophy, progressive supranuclear palsy)\n4. CNS or psychiatric disorders other than idiopathic PD (mild depression or anxiety arising in the context of PD is not exclusionary).\n5. Use of any symptomatic drug for PD other than levodopa, pramipexole, ropinirole, or Rotigotine within 60 days prior to the first dose.\n6. Patients with a history of brain surgery for PD (e.g., pallidotomy, thalamotomy, deep brain stimulation).\n7. Recent exposure to monoamine oxidase type A inhibitors, amphetamines, dopamine-depleting antihypertensive agents, neuroleptics, or antiemetics that block central dopamine activities.\n8. Unstable or clinically significant cardiovascular disease within the last year prior to screening (e.g., arrhythmias, conduction blocks, congestive heart failure.\n9. Concomitant disease or unstable medical condition within 6 months of screening that could interfere with the study or treatment.\n10. Participant has history of or presence of neuroleptic malignant syndrome at screening as assessed by the investigator.\n11. Participant has a current diagnosis of Epilepsy, has a history of seizures, stroke, or transient ischemic attack within 1 year prior to screening\n12. Presence of hepatitis B surface antigen (HBsAg) or positive for total hepatitis B core antibody (HbcAb), or positive hepatitis C (HCV) at screening.\n13. Vaccines other than SARS-CoV-2 vaccine within 28 days prior to the first dose or plans to receive vaccines during the study or within 28 days of the last dose.\n14. History of immunodeficiency disease (e.g., HIV).\n15. Clinically significant abnormalities in laboratory test results at screening, including hepatic and renal panels, complete blood count, chemistry panel, and urinalysis.\n16. Recently unresolved allergies, hypersensitivity, contact dermatitis or an active skin disease.\n17. Participants who have history of alcohol abuse within 6 months before screening as assessed by the investigator.\n18. Pregnant or lactating females","ALL","30 Years",{"count":62,"type":63},40,"ESTIMATED","INTERVENTIONAL",[66],"NA","A non-inferiority open-labelled crossover randomized controlled trial, of two arms, to investigate the adhesiveness and safety of Rotigexole 8 mg\u002F24 hours transdermal patch, manufactured by Eva pharma, Egypt, compared to the innovator product, Neupro® 8 mg\u002F 24 hours transdermal patch, manufactured by UCB Pharma S.A., Belgium, after 24 hours of application",[69],"Idiopathic Parkinson Disease",[71,72,73,74,75,76,77],"Rotigexole","Rotigotine","non-inferiority","open label","multicentric","randomized","cross-over","NOT_YET_RECRUITING","2025-08-06",{"date":81,"type":82},"2025-08-07","ACTUAL",{"date":84,"type":63},"2025-09-01",{"date":86,"type":63},"2025-10-30",{"name":5,"class":6}]