Adhesion and Safety of Rotigexole Compared to Neupro®

Launched by EVA PHARMA · Jun 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a new medication called Rotigexole, delivered through a skin patch, compared to an existing product called Neupro® in patients with idiopathic Parkinson's disease. The goal is to see if Rotigexole works just as well as Neupro® and to ensure it is safe for patients to use. The trial will involve adults aged 30 and older who have been diagnosed with Parkinson's disease but have not used certain Parkinson's medications in the month before the trial. Participants will need to be able to tolerate wearing the patch and will be asked to avoid swimming or bathing on the days they are being assessed.

Eligible participants will undergo a screening process to confirm their diagnosis and overall health. They will need to provide written consent and show they are using reliable contraception if they are women. If you or someone you know is considering participating, it's important to understand that this trial might not be for everyone, as certain health conditions or treatments could exclude someone from participating. Overall, this study aims to help improve treatment options for people living with Parkinson's disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or Female patients aged ≥30 years at Screening
• • 2. Diagnosed with idiopathic Parkinson's disease with a Hoehn and Yahr stage of II to III.
• • 3. 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
• • 4. Subjects should have a Mini Mental State Examination (MMSE) score of ≥25 at Screening.
• • 5. Participants who are able to tolerate Rotigotine transdermal patch incremental run-in period for 3 weeks.
• • 6. Willing to refrain from swimming, bathing or sauna use on assessment days.
• • 7. 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
• • 8. 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
• • 9. Ability to provide written informed consent.
• Exclusion Criteria:
• • 1. Patients with a medical history indicating a Parkinsonian syndrome other than idiopathic PD (e.g., drug-induced, post-stroke)
• • 2. History of significant skin hypersensitivity to adhesives or other transdermal products.
• • 3. History of or clinical features consistent with atypical parkinsonian syndromes (e.g., multiple system atrophy, progressive supranuclear palsy)
• • 4. CNS or psychiatric disorders other than idiopathic PD (mild depression or anxiety arising in the context of PD is not exclusionary).
• • 5. Use of any symptomatic drug for PD other than levodopa, pramipexole, ropinirole, or Rotigotine within 60 days prior to the first dose.
• • 6. Patients with a history of brain surgery for PD (e.g., pallidotomy, thalamotomy, deep brain stimulation).
• • 7. Recent exposure to monoamine oxidase type A inhibitors, amphetamines, dopamine-depleting antihypertensive agents, neuroleptics, or antiemetics that block central dopamine activities.
• • 8. Unstable or clinically significant cardiovascular disease within the last year prior to screening (e.g., arrhythmias, conduction blocks, congestive heart failure.
• • 9. Concomitant disease or unstable medical condition within 6 months of screening that could interfere with the study or treatment.
• • 10. Participant has history of or presence of neuroleptic malignant syndrome at screening as assessed by the investigator.
• • 11. Participant has a current diagnosis of Epilepsy, has a history of seizures, stroke, or transient ischemic attack within 1 year prior to screening
• • 12. Presence of hepatitis B surface antigen (HBsAg) or positive for total hepatitis B core antibody (HbcAb), or positive hepatitis C (HCV) at screening.
• • 13. 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.
• • 14. History of immunodeficiency disease (e.g., HIV).
• • 15. Clinically significant abnormalities in laboratory test results at screening, including hepatic and renal panels, complete blood count, chemistry panel, and urinalysis.
• • 16. Recently unresolved allergies, hypersensitivity, contact dermatitis or an active skin disease.
• • 17. Participants who have history of alcohol abuse within 6 months before screening as assessed by the investigator.
• • 18. Pregnant or lactating females