Comparative, Randomized, Open, Crossover Clinical Trial to Investigate Adhesiveness of a Newly Developed Rotigotine-containing Transdermal Patch in Patients With Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 8
- 主要终点
- Assessment of patch adhesion properties of the Test product in patients diagnosed with idiopathic Parkinson's disease at the end of the dosing interval
研究概览
简要总结
The investigational medicinal product (IMP) to be tested in the clinical trial (Rotigotine (ROT)-Transdermal System (TDS) (8 mg/24 h)), which is subject to this submission, was designed as a generic of Neupro® 8 mg/24 h, which is marketed in the European Union since 2006 (date of first authorisation is 2006, date of renewal of the authorisation is 2016) and serves as Reference product.
It is the intention of this clinical trial to assess patch adhesion properties of the newly developed rotigotine patch and the marketed Reference product Neupro® 8 mg/24 h after multiple patch applications.
详细描述
This multi-centre, open, randomized (order of treatments), multiple dose trial will be performed in a 4-period, 2-sequence-crossover design. A washout phase is not needed, i.e. the IMP application of the 2nd study period may take place the day of the IMP removal of the 1st study period (direct switch-over) and so forth.
Patients with a diagnosis of idiopathic Parkinson's disease and a continuous and stable dose of rotigotine (at least 8 mg/24 h) including use of an 8 mg/24 hours patch will be randomized.
In each of the 4 periods 1 patch, either of Test or Reference will be applied, with a release rate of 8 mg/24 h rotigotine each. Each patch will remain applied for 24 h.
Assessment of patch adhesion will be performed 5 min after application of each patch as well as at the end of the application interval prior to removal of the patch.
The clinical trial will be performed as a crossover investigation with intra-individual comparison, thus reducing variability of the patch adhesion parameters, which is supposed to be higher between patients than within an individual patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ethnic origin: Caucasian
- •age: 18 years or older
- •diagnosis of idiopathic Parkinson's disease
- •administration of a stable dose of at least 8 mg/24 h rotigotine including use of an 8 mg/24 h patch for at least 2 weeks prior to enrolment
- •agreement to refrain from swimming, bathing or using a sauna on the assessment days
- •written informed consent obtained, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the patients participating in the clinical trial
排除标准
- •Safety concerns
- •existing and/or history of significant skin hypersensitivity to adhesives or other transdermal products
- •existing and/or history of dermatitis (eczema; excluding seborrheic skin by Parkinson's disease)
- •existing and/or history of psoriasis
- •existing and/or history of an active skin disease which interferes with the rotigotine patch application according to the investigator's assessment
- •history of or current drug or alcohol dependence
- •existing medical condition or psychiatric condition which, in the opinion of the investigator, could jeopardize or compromise the patient's well-being or ability to participate in this study
- •lifetime history of suicide attempt
- •suicidal ideation in the past 6 months
- •administration of any investigational medicinal product during the last 2 months prior to individual enrolment of the patient
- •diagnosis of COVID-19 within the last 14 days prior to individual enrolment of the patient
- •contact to persons in foreign risk regions as defined by the Robert Koch Institute within the last 14 days prior to individual enrolment of the patient
- •known direct contact with insufficient protection to persons with diagnosis of COVID-19 within the last 14 days prior to individual enrolment upon reporting of the patient
- •For female patients with childbearing potential only:
- •positive pregnancy test at screening examination
- •pregnant or lactating women
- •female patients who do not agree to apply highly effective contraceptive methods
- •Administrative reasons
- •patients suspected or known not to follow instructions
- •patients who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial
研究组 & 干预措施
Sequence: Reference-Test-Reference-Test (RTRT)
Once daily patch application of one patch of Test or Reference over 4 days, i.e. a total of 4 alternating applications with RTRT sequence. Each patch remains applied for 24 h. Treatments may be directly switched without washout phase.
Period 1: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application
Period 2: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application
Period 3: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application
Period 4: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application
干预措施: Rotigotine 8Mg/24Hrs Patch (Drug)
Sequence: Test-Refrence-Test-Reference
Once daily patch application of one patch of Test or Reference over 4 days, i.e. a total of 4 alternating applications with TRTR sequence. Each patch remains applied for 24 h. Treatments may be directly switched without washout phase.
Period 1: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application
Period 2: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application
Period 3: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application
Period 4: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application
干预措施: Rotigotine 8Mg/24Hrs Patch (Drug)
结局指标
主要结局
Assessment of patch adhesion properties of the Test product in patients diagnosed with idiopathic Parkinson's disease at the end of the dosing interval
时间窗: 24 hours
Patch adhesion will be assessed for Test/ Reference 5 min and 23 h 55 min after patch application by trained observers. Area(s) detached will be drawn on transparent films of identical size and shape as the patch in question by the trained observer. As suggested by the Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1), June 2015, patch adhesion will be measured by means of the percentage of area that remains adhered at the end of the dosing interval. Additionally, the patch adhesion will be documented by taking photos at the time point of intended patch adhesion assessment of the patch and surrounding area. The following scores and affiliated percentages for the relative area still in tight contact with the skin will be used in order to quantify the patch adhesion: 0 = ≥ 90% adhered 1. = ≥ 80% adhered 2. = ≥ 70% adhered 3. = ≥ 60% adhered 4. = ≥ 50% adhered 5. = \< 50% adhered or patch completely off the skin.
Comparative assessment of patch adhesion properties of the Test vs. Reference product in patients diagnosed with idiopathic Parkinson's disease at the end of the dosing interval
时间窗: 24 hours
Patch adhesion will be assessed for Test/ Reference 5 min and 23 h 55 min after patch application by trained observers. Area(s) detached will be drawn on transparent films of identical size and shape as the patch in question by the trained observer. As suggested by the Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1), June 2015, patch adhesion will be measured by means of the percentage of area that remains adhered at the end of the dosing interval. Additionally, the patch adhesion will be documented by taking photos at the time point of intended patch adhesion assessment of the patch and surrounding area. The following scores and affiliated percentages for the relative area still in tight contact with the skin will be used in order to quantify the patch adhesion: 0 = ≥ 90% adhered 1. = ≥ 80% adhered 2. = ≥ 70% adhered 3. = ≥ 60% adhered 4. = ≥ 50% adhered 5. = \< 50% adhered or patch completely off the skin.
次要结局
- Skin tolerability of Test and Reference based on standardised assessment of Adverse Events of Special Interest(24 hours)
- Descriptive characterisation of safety and tolerability of the investigational medicinal products (IMPs) in the trial population(4 days)