Idiopathic Parkinson DiseaseSTARTNCT07015346
Adhesion and Safety of Rotigexole Compared to Neupro®
A study testing Rotigexole 8 mg and Neupro ® 8 mg in people with Idiopathic Parkinson Disease, run by Eva Pharma.
Trial 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.… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Idiopathic Parkinson Disease
- What is being tested?
- Rotigexole 8 mg and Neupro ® 8 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
- Participants who have history of alcohol abuse within 6 months before screening as assessed by the investigator.
- Pregnant or lactating females
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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
Read the detailed description
Study Design: 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.
Planned Treatment Duration per Subject and Study Duration per Subject:
The overall duration of the study preparation and study conduction is 7 weeks and 5 days (54 days) that are scheduled as follows:
- Preparatory Phase of the Study: Patients Screening (2 weeks): Patient screening for eligibility will occur over 14 days. During this time, all relevant administrative, demographic data collection, and informed consent will be conducted for eligible patients.
- Run-in-Phase (3 weeks):
- On the first day of the run-in phase, prior to drug administration, comprehensive physical and laboratory re-assessments will be conducted to document the initial patient's systemic status which will be monitored throughout the study to observe any potential systemic alterations for ethical purposes.
- The transdermal patch Rotigotine (Neupro ®) only will be applied in the run-in phase in a dose taper manner on weekly basis according to the European Medicines Agency (1) and the US FDA (2) recommendations for treating cases of PD. A starting dose of 4 mg/24 h initially, increasing in weekly increments of 2 mg/24 h (based on clinical response and tolerability) to a maximum of 8 mg/24 h; starting dose of 4 mg/24 h in the 1st week will be applied followed by 6 mg/24 h in the 2nd week and finally 8 mg/24 h in the 3rd week.
- The patch should be applied on clean, dry, healthy skin on the abdomen (tummy), thigh, hip, side, shoulder or upper arm.
- A Rotigotine transdermal patch necessitates daily replacement as the drug delivery lasts for 24 hours only (3-5). Notably, re-application at the same site should be avoided for 14 days.
- Comprehensive physical and laboratory assessments will be re-evaluated at the last day of the run-in-phase and prior to the commencement of the following intervention phase.
- Intervention Phase of the Study:
- This phase will last for five days only.
- At this phase patients will be randomly assigned to sequence of TRTR or RTRT (T=Test=Rotigexole, R=Reference= Neupro ®). Each transdermal patch, either T or R, will be replaced at the same time every 24 hours.
- Patients will receive accommodation for four nights during the intervention period to assess adhesion. Adhesion assessments will occur at 4, 8, 12 and 24 hours in accordance with FDA guidelines for transdermal patch evaluation.
- The application of the transdermal patches should be on different sites of the same region "abdomen (tummy), thigh, hip, side, shoulder or upper arm".
- Subjects must refrain from using topical products on the skin area designated for TDS application due to potential effects on adhesion. Additionally, hair at the application site should be clipped rather than shaved.
- The alternating transdermal patch should then be applied on the same site of the same region on the contralateral side.
- During this period, the patient is allowed to practice his or her routine activities without any restrictions in movement.
- Assessments will be performed just after application and will be repeated at 4, 8, 12 and 24 hours
- Patch reinforcement such as over-taping should be avoided.
- At each assessment, photographic documentation of TDS adhesion to the skin must be archived. This documentation serves to corroborate the visual evaluation of adhesion percentages recorded at each time point.
- At the final assessment of the 2nd transdermal patch application, the patient will be prescribed an alternative medicament (Ramixole) to stabilize the patient's conditions.
- Post-intervention Phase:
- All participants will undergo a comprehensive re-evaluation two weeks post-study to identify any systemic alterations for safety and ethical considerations (one follow-up visit).
- Any arising adverse systemic conditions in patients will be appropriately managed
- Conditions
- Idiopathic Parkinson Disease
- Being tested
- Rotigexole 8 mg, Neupro ® 8 mg
- Keywords
- Rotigexole, Rotigotine, non-inferiority, open label, multicentric, randomized, cross-over
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotigexole 8 mgDrug
Also called Rotigotine 8 mg
Rotigotine 8 mg
Neupro ® 8 mgDrug
Also called Rotigotine 8 mg
Rotigotine 8 mg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Neupro ® 8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: two treatment periods (4 days)
Adjusted Mean adherence percentage at each assessment time (4, 8, 12 and 24 hours).
Measured: 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.
Measured: two treatment periods (4 days)
Number of patches that are completely detached at 4, 8, 12 and 24 hours.
Measured: 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).
Measured: two treatment periods (4 days)
Number of participants with patch movement/displacement in each treatment period.
Measured: two treatment periods (4 days)
Number of participants with patch wrinkling in each treatment period.
Measured: two treatment periods (4 days)
Number of participants with patch residue formation in each treatment period (Patch residue formation is assessed at patch application on the release liner and at patch removal on the skin).
Measured: two treatment periods (4 days)
% of patients reporting ease or difficulty in patch application and removal.
Measured: two treatment periods (4 days)
Frequency of Adhesion-Related Issues: Evaluate the frequency of adhesion-related issues (e.g., patch detachment).
Measured: two treatment periods (4 days)
% of patients with reported interference in daily activities due to patch adhesion.
Measured: two treatment periods (4 days)
% of patients reporting overall satisfaction with wearing each patch type, measured using a Patch Wear Satisfaction Scale.
Measured: two treatment periods (4 days)
The incidence, seriousness and severity of adverse events (AEs) including application site reactions, and discontinuations because of AEs
Measured: two treatment periods (4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Sep 2025 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eva Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MARC-CRO
- Responsible party
- Sponsor
- Investigators
- Hatem S Mohammed, Dr., Principal investigator, Al-Manial Specialized Hospital - Cairo UniversityAli S Shalash, Dr., Principal investigator, Ain Shams Specialized Hospital - Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015346
- Sponsor's protocol ID
- START24042025
- Acronym
- START
- Status last verified
- Aug 2025
- First submitted
- 30 May 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07015346
- Acronym / sponsor ID
- START / START24042025
- Conditions
- Idiopathic Parkinson Disease
- Keywords
- Rotigexole, Rotigotine, non-inferiority, open label, multicentric, randomized, cross-over
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eva PharmaIndustry (pharma, biotech, devices)
- Collaborators
- MARC-CRO
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Study Design: 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.
Planned Treatment Duration per Subject and Study Duration per Subject:
The overall duration of the study preparation and study conduction is 7 weeks and 5 days (54 days) that are scheduled as follows:
- Preparatory Phase of the Study: Patients Screening (2 weeks): Patient screening for eligibility will occur over 14 days. During this time, all relevant administrative, demographic data collection, and informed consent will be conducted for eligible patients.
- Run-in-Phase (3 weeks):
- On the first day of the run-in phase, prior to drug administration, comprehensive physical and laboratory re-assessments will be conducted to document the initial patient's systemic status which will be monitored throughout the study to observe any potential systemic alterations for ethical purposes.
- The transdermal patch Rotigotine (Neupro ®) only will be applied in the run-in phase in a dose taper manner on weekly basis according to the European Medicines Agency (1) and the US FDA (2) recommendations for treating cases of PD. A starting dose of 4 mg/24 h initially, increasing in weekly increments of 2 mg/24 h (based on clinical response and tolerability) to a maximum of 8 mg/24 h; starting dose of 4 mg/24 h in the 1st week will be applied followed by 6 mg/24 h in the 2nd week and finally 8 mg/24 h in the 3rd week.
- The patch should be applied on clean, dry, healthy skin on the abdomen (tummy), thigh, hip, side, shoulder or upper arm.
- A Rotigotine transdermal patch necessitates daily replacement as the drug delivery lasts for 24 hours only (3-5). Notably, re-application at the same site should be avoided for 14 days.
- Comprehensive physical and laboratory assessments will be re-evaluated at the last day of the run-in-phase and prior to the commencement of the following intervention phase.
- Intervention Phase of the Study:
- This phase will last for five days only.
- At this phase patients will be randomly assigned to sequence of TRTR or RTRT (T=Test=Rotigexole, R=Reference= Neupro ®). Each transdermal patch, either T or R, will be replaced at the same time every 24 hours.
- Patients will receive accommodation for four nights during the intervention period to assess adhesion. Adhesion assessments will occur at 4, 8, 12 and 24 hours in accordance with FDA guidelines for transdermal patch evaluation.
- The application of the transdermal patches should be on different sites of the same region "abdomen (tummy), thigh, hip, side, shoulder or upper arm".
- Subjects must refrain from using topical products on the skin area designated for TDS application due to potential effects on adhesion. Additionally, hair at the application site should be clipped rather than shaved.
- The alternating transdermal patch should then be applied on the same site of the same region on the contralateral side.
- During this period, the patient is allowed to practice his or her routine activities without any restrictions in movement.
- Assessments will be performed just after application and will be repeated at 4, 8, 12 and 24 hours
- Patch reinforcement such as over-taping should be avoided.
- At each assessment, photographic documentation of TDS adhesion to the skin must be archived. This documentation serves to corroborate the visual evaluation of adhesion percentages recorded at each time point.
- At the final assessment of the 2nd transdermal patch application, the patient will be prescribed an alternative medicament (Ramixole) to stabilize the patient's conditions.
- Post-intervention Phase:
- All participants will undergo a comprehensive re-evaluation two weeks post-study to identify any systemic alterations for safety and ethical considerations (one follow-up visit).
- Any arising adverse systemic conditions in patients will be appropriately managed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Test: Rotigexole 8 mg/24 hours transdermal patch | Experimental | Drug: Rotigexole 8 mgAt 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. |
| Reference: Neupro® 8 mg/ 24 hours transdermal patch | Active comparator | Drug: Neupro ® 8 mgAt 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotigexole 8 mgAlso: Rotigotine 8 mgRotigotine 8 mg | Drug | Test: Rotigexole 8 mg/24 hours transdermal patch |
| Neupro ® 8 mgAlso: Rotigotine 8 mgRotigotine 8 mg | Drug | Reference: Neupro® 8 mg/ 24 hours transdermal patch |
Primary outcome
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)
Time frame: two treatment periods (4 days)
Using a mixed-effects model adjusted for period and sequence effects, with subject as a random effect
13 secondary outcomes
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.
Time frame: two treatment periods (4 days)
Adjusted Mean adherence percentage at each assessment time (4, 8, 12 and 24 hours).
Time frame: 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.
Time frame: two treatment periods (4 days)
Number of patches that are completely detached at 4, 8, 12 and 24 hours.
Time frame: 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).
Time frame: two treatment periods (4 days)
Number of participants with patch movement/displacement in each treatment period.
Time frame: two treatment periods (4 days)
Number of participants with patch wrinkling in each treatment period.
Time frame: two treatment periods (4 days)
Number of participants with patch residue formation in each treatment period (Patch residue formation is assessed at patch application on the release liner and at patch removal on the skin).
Time frame: two treatment periods (4 days)
% of patients reporting ease or difficulty in patch application and removal.
Time frame: two treatment periods (4 days)
Frequency of Adhesion-Related Issues: Evaluate the frequency of adhesion-related issues (e.g., patch detachment).
Time frame: two treatment periods (4 days)
% of patients with reported interference in daily activities due to patch adhesion.
Time frame: two treatment periods (4 days)
% of patients reporting overall satisfaction with wearing each patch type, measured using a Patch Wear Satisfaction Scale.
Time frame: two treatment periods (4 days)
The incidence, seriousness and severity of adverse events (AEs) including application site reactions, and discontinuations because of AEs
Time frame: two treatment periods (4 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hatem S Mohammed, Dr. principal investigator
Al-Manial Specialized Hospital - Cairo University
Ali S Shalash, Dr. principal investigator
Ain Shams Specialized Hospital - Ain Shams University
Questions about this trial
What is this clinical trial studying?
A study testing Rotigexole 8 mg and Neupro ® 8 mg in people with Idiopathic Parkinson Disease, run by Eva Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lydia Bahig (01225952401, lydia.bahig@marc-eg.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: two treatment periods (4 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.