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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

Rotigexole 8 mg
Drug
Rotigotine 8 mg
Neupro ® 8 mg
Drug
Rotigotine 8 mg

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Test: Rotigexole 8 mg/24 hours transdermal patchExperimental treatment 1 intervention

Group B: Reference: Neupro® 8 mg/ 24 hours transdermal patchActive comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Using a mixed-effects model adjusted for period and sequence effects, with subject as a random effect

Time frame