Adhesion and Safety of Rotigexole Compared to Neupro®
ConditionIdiopathic Parkinson Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorEva Pharma
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Rotigexole 8 mg
- Neupro ® 8 mg
Treatment groups
40 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Eva Pharma
Lead sponsor
MARC-CRO
Collaborator
Source ClinicalTrials.gov