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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Eva Pharma
- 入组人数
- 40
- 主要终点
- 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)
研究概览
简要总结
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
详细描述
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. 2. Run-in-Phase (3 weeks):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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
研究组 & 干预措施
Test: Rotigexole 8 mg/24 hours transdermal patch
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.
干预措施: Rotigexole 8 mg (Drug)
Reference: Neupro® 8 mg/ 24 hours transdermal patch
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.
干预措施: Neupro ® 8 mg (Drug)
结局指标
主要结局
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)
时间窗: two treatment periods (4 days)
Using a mixed-effects model adjusted for period and sequence effects, with subject as a random effect
次要结局
- 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))
- 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))
- Number of participants with patch movement/displacement in each treatment period.(two treatment periods (4 days))
- Number of participants with patch wrinkling in each treatment period.(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 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).(two treatment periods (4 days))
- % of patients reporting ease or difficulty in patch application and removal.(two treatment periods (4 days))
- Frequency of Adhesion-Related Issues: Evaluate the frequency of adhesion-related issues (e.g., patch detachment).(two treatment periods (4 days))
- % of patients with reported interference in daily activities due to patch adhesion.(two treatment periods (4 days))
- % of patients reporting overall satisfaction with wearing each patch type, measured using a Patch Wear Satisfaction Scale.(two treatment periods (4 days))
- The incidence, seriousness and severity of adverse events (AEs) including application site reactions, and discontinuations because of AEs(two treatment periods (4 days))