Phase 1
Completed N=57
A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease
Source: ClinicalTrials.gov NCT02230904 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: 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 — 1.04; 2.15 units on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
1.04; 2.15 | — |
| SECONDARY 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 |
65.4; 46.2; 11.5; 17.3; 7.7; 5.8 | — |
| SECONDARY Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2 |
71.2; 36.5; 5.8; 7.7; 3.8; 9.6 | — |
| SECONDARY 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 |
76.9; 63.5; 15.4; 17.3; 1.9; 11.5 | — |
| SECONDARY 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 |
76.9; 44.2; 11.5; 28.8; 3.8; 17.3 | — |
| SECONDARY Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1 |
75.0; 65.4; 17.3; 13.5; 3.8; 9.6 | — |
| SECONDARY Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2 |
73.1; 59.6; 15.4; 26.9; 9.6; 5.8 | — |
| SECONDARY 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 |
0.40; 0.85 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT02230904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.