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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04183634
Recruitment Status : Terminated (Company Decision)
First Posted : December 3, 2019
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Rotigotine TTS (Test) Drug: Neupro (Reference) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.
Actual Study Start Date : December 3, 2019
Actual Primary Completion Date : March 16, 2020
Actual Study Completion Date : March 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions
Drug Information available for: Rotigotine

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.




Primary Outcome Measures :
  1. Patch Adhesion [ Time Frame: 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 :
  1. Number of patients with cold flow [ Time Frame: 24 hours in each Treatment Period ]
    Cold flow is defined as dark ring formed around the patch

  2. Number of patients with patch movement/displacement [ Time Frame: 24 hours in each Treatment Period ]
  3. Number of patients with patch wrinkling [ Time Frame: 24 hours in each Treatment Period ]
  4. Number of patients with patch residue formation [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04183634


Locations
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Germany
Sandoz Investigative Site
Hamburg, Germany
Sponsors and Collaborators
Sandoz
Investigators
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Study Director: Sandoz Sandoz
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Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT04183634    
Other Study ID Numbers: 2019-06-TTS-10
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sandoz:
adhesiveness
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs