A Multicenter, Randomized, Double-blind, 2-way Cross-over Study to Compare the Adhesiveness of 2 Different Rotigotine Patch Formulations in Subjects With Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 11
- 主要终点
- Change in Average Adhesiveness Score of 2 Days of 24 Hours Patch Application as Rated by the Investigator (or Designee) Assessed According to the EMA Draft Guideline
研究概览
简要总结
The primary objective of the study is to compare the adhesiveness of 2 different patch formulations of Rotigotine using the largest patch size of 40 cm^2, under the assumption that both patch formulations show similar adhesiveness properties.
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
- Double (Participant, Investigator)
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
- •Subject has a diagnosis of idiopathic Parkinson's Disease
- •Subject has been on continuous treatment with commercially available Rotigotine transdermal patches (Neupro®) for at least 3 months prior to enrollment
- •Subject has been taking a stable Rotigotine dose including an 8 mg/24 hours (40 cm^2) patch for at least 2 weeks prior to enrollment
排除标准
- •Subject has any medical or psychiatric condition which, in the opinion of the investigator, could jeopardize or would compromise the subject's well-being or ability to participate in this study
- •Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recently unsolved contact dermatitis
- •Subject has a history or present condition of an atopic or eczematous Dermatitis, Psoriasis, or an active skin disease
- •Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1) or Baseline (Visit 2)
研究组 & 干预措施
Treatment Arm A-B
4 day treatment (Treatment A: Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B: Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)
干预措施: Rotigotine (Test product PR 2.3.1) (Drug)
Treatment Arm A-B
4 day treatment (Treatment A: Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B: Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)
干预措施: Rotigotine (Reference product PR 2.1.1) (Drug)
Treatment Arm B-A
4 day treatment (Treatment B: Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A: Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)
干预措施: Rotigotine (Test product PR 2.3.1) (Drug)
Treatment Arm B-A
4 day treatment (Treatment B: Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A: Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)
干预措施: Rotigotine (Reference product PR 2.1.1) (Drug)
结局指标
主要结局
Change in Average Adhesiveness Score of 2 Days of 24 Hours Patch Application as Rated by the Investigator (or Designee) Assessed According to the EMA Draft Guideline
时间窗: Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012). * 0 = \> 95 - 100 % of the patch area adheres * 1 = \> 90 - 95 % of the patch adheres * 2 = \> 85 - 90 % of the patch adheres * 3 = \> 80 - 85 % of the patch adheres * 4 = \> 75 - 80 % of the patch adheres * 5 = \> 70 - 75 % of the patch adheres * 6 = ≥ 50 - 70 % of the patch adheres * 7 = \< 50 % of the patch adheres * 8 = Patch completely detached The recorded scores 6, 7, and 8 were combined in order to create a cumulative group "less than or equal to 70 % adhered or patch detachment" which was regarded as significant patch adhesion failure in the draft EMA guideline. The average of patches 1 and 2 is presented by Treatment Arm below.
次要结局
- Patch Adhesiveness Per Day as Rated by the Investigator or Designee 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 1(Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4)
- Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 1(Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4)
- Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1(Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4)
- Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2(Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5)
- Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2(Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5)
- Change in Average Patch Adhesiveness Score of 2 Days of 24 Hour Patch Application as Rated by the Investigator (or Designee), Assessed According to the FDA/Center for Drug Evaluation and Research (CDER) Score(Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5)
- Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 2(Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5)