Adhesion and Safety of Rotigexole Compared to Neupro®

Korábbi kezelés

• Use of any symptomatic drug for PD other than levodopa, pramipexole, ropinirole, or Rotigotine within 60 days prior to the first dose.
• Recent exposure to monoamine oxidase type A inhibitors, amphetamines, dopamine-depleting antihypertensive agents, neuroleptics, or antiemetics that block central dopamine activities.
• Unstable or clinically significant cardiovascular disease within the last year prior to screening (e.g., arrhythmias, conduction blocks, congestive heart failure.
• Concomitant disease or unstable medical condition within 6 months of screening that could interfere with the study or treatment.
• Participant has a current diagnosis of Epilepsy, has a history of seizures, stroke, or transient ischemic attack within 1 year prior to screening
• 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.
• Participants who have history of alcohol abuse within 6 months before screening as assessed by the investigator.

Más betegség

• Patients with a medical history indicating a Parkinsonian syndrome other than idiopathic PD (e.g., drug-induced, post-stroke)
• History of significant skin hypersensitivity to adhesives or other transdermal products.
• History of or clinical features consistent with atypical parkinsonian syndromes (e.g., multiple system atrophy, progressive supranuclear palsy)
• CNS or psychiatric disorders other than idiopathic PD (mild depression or anxiety arising in the context of PD is not exclusionary).
• Patients with a history of brain surgery for PD (e.g., pallidotomy, thalamotomy, deep brain stimulation).
• Participant has history of or presence of neuroleptic malignant syndrome at screening as assessed by the investigator.
• Presence of hepatitis B surface antigen (HBsAg) or positive for total hepatitis B core antibody (HbcAb), or positive hepatitis C (HCV) at screening.
• History of immunodeficiency disease (e.g., HIV).
• Recently unresolved allergies, hypersensitivity, contact dermatitis or an active skin disease.

Laborértékek

• Clinically significant abnormalities in laboratory test results at screening, including hepatic and renal panels, complete blood count, chemistry panel, and urinalysis.

Egyéb

• Pregnant or lactating females

• Male or Female patients aged ≥30 years at Screening
• Diagnosed with idiopathic Parkinson's disease with a Hoehn and Yahr stage of II to III.
• 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
• Subjects should have a Mini Mental State Examination (MMSE) score of ≥25 at Screening.
• Participants who are able to tolerate Rotigotine transdermal patch incremental run-in period for 3 weeks.
• Willing to refrain from swimming, bathing or sauna use on assessment days.
• 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
• 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
• Ability to provide written informed consent.