An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.

Phase 1

Terminated

• Conditions: Parkinson Disease
• Interventions: Drug: Rotigotine TTS (Test); Drug: Neupro (Reference)

• Registration Number: NCT04183634
• Lead Sponsor: Sandoz

Brief Summary

The objective of this study is to evaluate the adhesion of the test product when compared to the reference product following a single transdermal application.

Detailed Description

The objective of this clinical trial is to evaluate the adhesion of the test product when compared to the reference product following a single transdermal application.

The following evaluations will be assessed as "yes" or "no":

* Cold flow (dark ring formed around the patch)

* Patch movement/displacement

* Patch wrinkling

* Residue formation (at patch application on the release liner and at patch removal on the skin) Safety and tolerability of a single dose application of a patch containing 18 mg rotigotine (Test) against a patch containing 18 mg rotigotine (Reference) will be evaluated in terms of vital signs and AEs.

AEs and clinical tolerability will be monitored at all clinical trial visits. The safety evaluation will be based upon the review of the individual values (potentially clinically important abnormalities) and descriptive statistics (summary tables, graphics).

As additional safety parameters for the clinical trial physical examination findings, clinical laboratory parameters, and 12-lead ECGs will be assessed at the screening and follow-up.

Study Timeline

• Study First Submitted: 2019-11-28
• Study First Submitted QC: 2019-11-28
• Study Start: 2019-12-03
• Study First Posted: 2019-12-03
• Primary Completion: 2020-03-16
• Study Completion: 2020-03-16
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Patients diagnosed with idiopathic Parkinson's Disease assessed as eligible for receiving 18 mg/IRR 8 mg/24 h rotigotine via the test and the reference product each on subsequent days in order to reach the dose of active substance at the individual routine medical care. Patients should be on a stable rotigotine dose of at least 8 mg/24 h for at least 1 week before screening.

Exclusion Criteria

• Current participation in another clinical trial, participation in another clinical study (i.e. last protocol specified visit) involving another IMP within at least 28 days prior to first application or previous participation in this clinical Trial
• History or presence of clinically significant dermatologic diseases or conditions, such as atopy, neurodermatitis, contact allergy, eczema, psoriasis, vitiligo, melanoma, squamous cell carcinoma.
• History or presence of any dermatological condition or skin sensitivity that could affect IMP Absorption
• History of clinically relevant (severe) hypersensitivity to the active pharmaceutical ingredient or substances of the same class or one of the excipients, clinically relevant allergy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Period 1: Rotigotine TTS (Test) - Period 2: Neupro (Reference)	Neupro (Reference)	For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h
Period 1: Rotigotine TTS (Test) - Period 2: Neupro (Reference)	Rotigotine TTS (Test)	For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h
Period 1: Neupro (Reference) - Period 2: Rotigotine TTS (Test)	Rotigotine TTS (Test)	For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h
Period 1: Neupro (Reference) - Period 2: Rotigotine TTS (Test)	Neupro (Reference)	For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h

Primary Outcome Measures

Name	Time	Method
Patch Adhesion	24 hours in each Treatment Period	Patch Adhesion will be measured as the percentage of area that remained adhered after 24 hours of patch application.

Secondary Outcome Measures

Name	Time	Method
Number of patients with cold flow	24 hours in each Treatment Period	Cold flow is defined as dark ring formed around the patch
Number of patients with patch movement/displacement	24 hours in each Treatment Period
Number of patients with patch wrinkling	24 hours in each Treatment Period
Number of patients with patch residue formation	24 hours in each Treatment Period	Patch residue formation is assessed at patch application on the release liner and at patch removal on the skin.

Trial Locations

Locations (1)

Sandoz Investigative Site; 🇩🇪 Hamburg, Germany