Not Yet RecruitingNot Applicable

Adhesion and Safety of Rotigexole Compared to Neupro®

40 participantsStarted 2025-09-01

Plain-language summary

A non-inferiority open-labelled crossover randomized controlled trial, of two arms, to investigate the adhesiveness and safety of Rotigexole 8 mg/24 hours transdermal patch, manufactured by Eva pharma, Egypt, compared to the innovator product, Neupro® 8 mg/ 24 hours transdermal patch, manufactured by UCB Pharma S.A., Belgium, after 24 hours of application

Who can participate

Age range30 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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).
✕. Use of any symptomatic drug for PD other than levodopa, pramipexole, ropinirole, or Rotigotine within 60 days prior to the first dose.
✕. Patients with a history of brain surgery for PD (e.g., pallidotomy, thalamotomy, deep brain stimulation).
✕. 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.

What they're measuring

The cumulative mean percentage adhesion of the transdermal patch over the 24-hour dosing interval for two treatment periods, compared between Rotigexole (Test) and Neupro® (Reference)

Timeframe: two treatment periods (4 days)

Trial details

NCT IDNCT07015346

SponsorEva Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-15

Contact for this trial

Lydia Bahig

01225952401 lydia.bahig@marc-eg.org

View on ClinicalTrials.gov More Idiopathic Parkinson Disease trials