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Completed

NCT Number: NCT02230904

A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease

The primary objective of the study is to compare the adhesiveness of 2 different patch formulations of Rotigotine using the largest patch size of 40 cm^2, under the assumption that both patch formulations show similar adhesiveness properties.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

104, Alzenau in Unterfranken, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has a diagnosis of idiopathic Parkinson's Disease
  • Subject has been on continuous treatment with commercially available Rotigotine transdermal patches (Neupro®) for at least 3 months prior to enrollment
  • Subject has been taking a stable Rotigotine dose including an 8 mg/24 hours (40 cm^2) patch for at least 2 weeks prior to enrollment

Exclusion criteria

  • Subject has any medical or psychiatric condition which, in the opinion of the investigator, could jeopardize or would compromise the subject's well-being or ability to participate in this study
  • Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recently unsolved contact dermatitis
  • Subject has a history or present condition of an atopic or eczematous Dermatitis, Psoriasis, or an active skin disease
  • Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1) or Baseline (Visit 2)

Treatment and study plan

Rotigotine (Test product PR 2.3.1)

Drug
  • Pharmaceutical form: Transdermal patch
  • Concentration: 8 mg/24 hours
  • Route of administration: Transdermal

Rotigotine (Reference product PR 2.1.1)

Drug
  • Pharmaceutical form: Transdermal patch
  • Concentration: 8 mg/24 hours
  • Route of administration: Transdermal

Other names: Neupro

Primary outcomes

  1. Change in Average Adhesiveness Score of 2 Days of 24 Hours Patch Application as Rated by the Investigator (or Designee) Assessed According to the EMA Draft Guideline

    Time frame: Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5

    The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).

    • 0 = > 95 - 100 % of the patch area adheres
    • 1 = > 90 - 95 % of the patch adheres
    • 2 = > 85 - 90 % of the patch adheres
    • 3 = > 80 - 85 % of the patch adheres
    • 4 = > 75 - 80 % of the patch adheres
    • 5 = > 70 - 75 % of the patch adheres
    • 6 = ≥ 50 - 70 % of the patch adheres
    • 7 = < 50 % of the patch adheres
    • 8 = Patch completely detached

    The recorded scores 6, 7, and 8 were combined in order to create a cumulative group "less than or equal to 70 % adhered or patch detachment" which was regarded as significant patch adhesion failure in the draft EMA guideline.

    The average of patches 1 and 2 is presented by Treatment Arm below.

Secondary outcomes

  1. Patch Adhesiveness Per Day as Rated by the Investigator or Designee 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 1

    Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4

    The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).

    • 0 = >95 - 100 % of the patch area adheres
    • 1 = >90 - 95 % of the patch adheres
    • 2 = >85 - 90 % of the patch adheres
    • 3 = >80 - 85 % of the patch adheres
    • 4 = >75 - 80 % of the patch adheres
    • 5 = >70 - 75 % of the patch adheres
    • 6 = ≥50 - 70 % of the patch adheres
    • 7 = <50 % of the patch adheres
    • 8 = Patch completely detached

    The recorded scores 6, 7, and 8 were combined in order to create a cumulative group "less than or equal to 70 % adhered or patch detachment" which was regarded as significant patch adhesion failure in the draft EMA guideline.

  2. Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2

    Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5

    The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).

    • 0 = >95 - 100 % of the patch area adheres
    • 1 = >90 - 95 % of the patch adheres
    • 2 = >85 - 90 % of the patch adheres
    • 3 = >80 - 85 % of the patch adheres
    • 4 = >75 - 80 % of the patch adheres
    • 5 = >70 - 75 % of the patch adheres
    • 6 = ≥50 - 70 % of the patch adheres
    • 7 = <50 % of the patch adheres
    • 8 = Patch completely detached

    The recorded scores 6, 7, and 8 were combined in order to create a cumulative group "less than or equal to 70 % adhered or patch detachment" which was regarded as significant patch adhesion failure in the draft EMA guideline.

  3. Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 1

    Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4

    The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:

    • 0 (>95-100% of patch adheres) >> 0 (FDA/CDER)
    • 1 (>90-95% of patch adheres) >> 0 (FDA/CDER)
    • 2 (>85-90% of patch adheres) >> 1 (FDA/CDER)
    • 3 (>80-85% of patch adheres) >> 1 (FDA/CDER)
    • 4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)
    • 5 (>70-75% of patch adheres) >> 2 (FDA/CDER)
    • 6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)
    • 7 (<50 % of patch adheres) >> 3 (FDA/CDER)
    • 8 (Patch completely detached) >> 4 (FDA/CDER)

    Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies.

  4. Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 2

    Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5

    The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:

    • 0 (>95-100% of patch adheres) >> 0 (FDA/CDER)
    • 1 (>90-95% of patch adheres) >> 0 (FDA/CDER)
    • 2 (>85-90% of patch adheres) >> 1 (FDA/CDER)
    • 3 (>80-85% of patch adheres) >> 1 (FDA/CDER)
    • 4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)
    • 5 (>70-75% of patch adheres) >> 2 (FDA/CDER)
    • 6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)
    • 7 (<50 % of patch adheres) >> 3 (FDA/CDER)
    • 8 (Patch completely detached) >> 4 (FDA/CDER)

    Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies.

  5. Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1

    Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4

    The subject assessed the patch adhesiveness by using the following score:

    • 0 = Satisfied with adhesiveness
    • 1 = Moderately satisfied with adhesiveness
    • 2 = Moderately unsatisfied with adhesiveness
    • 3 = Unsatisfied with adhesiveness

  6. Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2

    Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5

    The subject assessed the patch adhesiveness by using the following score:

    • 0 = Satisfied with adhesiveness
    • 1 = Moderately satisfied with adhesiveness
    • 2 = Moderately unsatisfied with adhesiveness
    • 3 = Unsatisfied with adhesiveness

  7. Change in Average Patch Adhesiveness Score of 2 Days of 24 Hour Patch Application as Rated by the Investigator (or Designee), Assessed According to the FDA/Center for Drug Evaluation and Research (CDER) Score

    Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5

    The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:

    • 0 (>95-100% of patch adheres) >> 0 (FDA/CDER)
    • 1 (>90-95% of patch adheres) >> 0 (FDA/CDER)
    • 2 (>85-90% of patch adheres) >> 1 (FDA/CDER)
    • 3 (>80-85% of patch adheres) >> 1 (FDA/CDER)
    • 4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)
    • 5 (>70-75% of patch adheres) >> 2 (FDA/CDER)
    • 6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)
    • 7 (<50 % of patch adheres) >> 3 (FDA/CDER)
    • 8 (Patch completely detached) >> 4 (FDA/CDER)

    Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies.

Sponsors and collaborators

Lead sponsor

UCB BIOSCIENCES GmbH

Industry

Collaborators

  • Bracket Global
  • Pharmaceutical Health Sciences

Registry information

Official study title

A Multicenter, Randomized, Double-blind, 2-way Cross-over Study to Compare the Adhesiveness of 2 Different Rotigotine Patch Formulations in Subjects With Parkinson's Disease

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 3, 2014
Registry last updated
Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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