Adhesion and Safety of Rotigexole Compared to Neupro®

NCT07015346 | Not Yet Recruiting

• 1 other identifier: START24042025
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Idiopathic Parkinson Disease

Keywords

Rotigexole; Rotigotine; non-inferiority; open label; multicentric; randomized; cross-over

Outcome Measures

Primary Outcomes (1)

• 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

  two treatment periods (4 days)

Secondary Outcomes (13)

• Proportion of participants achieving more than 90% adherence at 4, 8, 12 and 24 hours at each period as assessed by the investigator/designee as per modified EMA scale for adhesion.

  two treatment periods (4 days)

• Adjusted Mean adherence percentage at each assessment time (4, 8, 12 and 24 hours).

  two treatment periods (4 days)

• Proportion of participants with a meaningful degree of detachment (more than half of the patch lifting off the skin or falling off) at 4, 8, 12 and 24 hours.

  two treatment periods (4 days)

• Number of patches that are completely detached at 4, 8, 12 and 24 hours.

  two treatment periods (4 days)

• Number of participants with cold flow in each treatment period (Cold flow is defined as dark ring formed around the patch).

  two treatment periods (4 days)

Study Arms (2)

Test: Rotigexole 8 mg/24 hours transdermal patch

EXPERIMENTAL

At the beginning of the intervention phase, patients' randomization will take place to determine the sequence of reference (R) and test (T) administration to either RTRT group or TRTR group. After obtaining all baseline characteristics, once daily patch application of one patch of 8 mg/24 h of Test (T) or Reference (R) over 4 days, i.e. a total of 4 alternating applications with RT sequence or TR sequence will be administered. Each patch remains applied for 24 h and the treatment patches may be directly switched without washout phase.

Drug: Rotigexole 8 mg

Reference: Neupro® 8 mg/ 24 hours transdermal patch

ACTIVE COMPARATOR

At the beginning of the intervention phase, patients' randomization will take place to determine the sequence of reference (R) and test (T) administration to either RTRT group or TRTR group. After obtaining all baseline characteristics, once daily patch application of one patch of 8 mg/24 h of Test (T) or Reference (R) over 4 days, i.e. a total of 4 alternating applications with RT sequence or TR sequence will be administered. Each patch remains applied for 24 h and the treatment patches may be directly switched without washout phase.

Drug: Neupro ® 8 mg

Interventions

Rotigexole 8 mg DRUG

Rotigotine 8 mg

Also known as: Rotigotine 8 mg

Test: Rotigexole 8 mg/24 hours transdermal patch

Neupro ® 8 mg DRUG

Rotigotine 8 mg

Also known as: Rotigotine 8 mg

Reference: Neupro® 8 mg/ 24 hours transdermal patch

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.
• Concomitant disease or unstable medical condition within 6 months of screening that could interfere with the study or treatment.
• Participant has history of or presence of neuroleptic malignant syndrome at screening as assessed by the investigator.
• Participant has a current diagnosis of Epilepsy, has a history of seizures, stroke, or transient ischemic attack within 1 year prior to screening
• Presence of hepatitis B surface antigen (HBsAg) or positive for total hepatitis B core antibody (HbcAb), or positive hepatitis C (HCV) at 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.
• History of immunodeficiency disease (e.g., HIV).
• Clinically significant abnormalities in laboratory test results at screening, including hepatic and renal panels, complete blood count, chemistry panel, and urinalysis.
• Recently unresolved allergies, hypersensitivity, contact dermatitis or an active skin disease.

Sponsors & Collaborators

• Eva Pharma: lead
• MARC-CRO: collaborator

Related Links

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MeSH Terms

Conditions

Parkinson Disease

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Hatem S Mohammed, Dr.

  Al-Manial Specialized Hospital - Cairo University

  PRINCIPAL INVESTIGATOR

• Ali S Shalash, Dr.

  Ain Shams Specialized Hospital - Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lydia Bahig

CONTACT

01225952401; lydia.bahig@marc-eg.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: After signing the ICF, eligible patients will be enrolled in a 3-week run-in phase using Neupro ® gradually increasing the dose from 4 mg to 6mg then to 8 mg in weekly increments. Patches are applied to clean, healthy skin on rotating body sites and replaced every 24 hours, with no reuse of the same site within 14 days. After this phase, participants enter a 5-day intervention where they receive either Rotigexole or Neupro® in alternating sequences, with patch adhesion monitored at set intervals. Patients stay in a controlled setting during this phase, and patch application follows strict site rotation and documentation protocols. Following the intervention, patients are stabilized with Ramixole and undergo a final safety evaluation two weeks later.

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 11, 2025
• Study Start: September 1, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 30, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share