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

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.

Study Overview

• Status: Terminated
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Rotigotine TTS (Test); Drug: Neupro (Reference)

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • Sandoz Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Period 1: Rotigotine TTS (Test) - Period 2: Neupro (Reference); For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h	Drug: Rotigotine TTS (Test); Transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24.; Drug: Neupro (Reference); Neupro®: transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24 h.
Active Comparator: Period 1: Neupro (Reference) - Period 2: Rotigotine TTS (Test); For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h	Drug: Rotigotine TTS (Test); Transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24.; Drug: Neupro (Reference); Neupro®: transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24 h.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with cold flow	Cold flow is defined as dark ring formed around the patch	24 hours in each Treatment Period
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	Patch residue formation is assessed at patch application on the release liner and at patch removal on the skin.	24 hours in each Treatment Period

Collaborators and Investigators

• Sponsor: Sandoz

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2019
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): March 16, 2020

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: November 28, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: adhesiveness
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Rotigotine
• Other Study ID Numbers: 2019-06-TTS-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No