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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04183634
• Other study ID #: 2019-06-TTS-10
• Status: Terminated
• Phase: Phase 1
• Start date: December 3, 2019
• Est. completion date: March 16, 2020

Study information

• Verified date: November 2020
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Rotigotine TTS (Test)
Transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24.
• Neupro (Reference)
Neupro®: transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24 h.

Locations

Country	Name	City	State
Germany	Sandoz Investigative Site	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients with cold flow	Cold flow is defined as dark ring formed around the patch	24 hours in each Treatment Period
Secondary	Number of patients with patch movement/displacement		24 hours in each Treatment Period
Secondary	Number of patients with patch wrinkling		24 hours in each Treatment Period
Secondary	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

External Links

•   Study Results