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

NCT ID: NCT04183634

Last Updated: 2020-11-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-03
• Study Completion Date: 2020-03-16

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.

Conditions

Parkinson Disease

Keywords

adhesiveness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Rotigotine TTS (Test)

Intervention Type: DRUG

Transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24.

Neupro (Reference)

Intervention Type: DRUG

Neupro®: transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24 h.

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

Group Type: ACTIVE_COMPARATOR

Rotigotine TTS (Test)

Intervention Type: DRUG

Transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24.

Neupro (Reference)

Intervention Type: DRUG

Neupro®: transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24 h.

Interventions

Rotigotine TTS (Test)

Transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24.

Intervention Type: DRUG

Neupro (Reference)

Neupro®: transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24 h.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sandoz

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandoz

Role: STUDY_DIRECTOR

Sandoz

Locations

Sandoz Investigative Site

Hamburg, , Germany

Countries

Germany

Other Identifiers

2019-06-TTS-10

Identifier Type: -

Identifier Source: org_study_id