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

NCT02230904 | Completed Phase 1 Results

• 2 other identifiers: PD00182014-000932-41
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Parkinson's Disease

Keywords

Rotigotine patch; Neupro; Parkinson's Disease

Outcome Measures

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

  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.

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

Secondary Outcomes (7)

• 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

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

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

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

• 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

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

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

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

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

Study Arms (2)

Treatment Arm A-B

EXPERIMENTAL

4 day treatment (Treatment A: Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B: Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)

Drug: Rotigotine (Test product PR 2.3.1); Drug: Rotigotine (Reference product PR 2.1.1)

Treatment Arm B-A

EXPERIMENTAL

4 day treatment (Treatment B: Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A: Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)

Drug: Rotigotine (Test product PR 2.3.1); Drug: Rotigotine (Reference product PR 2.1.1)

Interventions

Rotigotine (Test product PR 2.3.1) DRUG

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

Treatment Arm A-B; Treatment Arm B-A

Rotigotine (Reference product PR 2.1.1) DRUG

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

Also known as: Neupro

Treatment Arm A-B; Treatment Arm B-A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• UCB BIOSCIENCES GmbH: lead
• Pharmaceutical Health Sciences: collaborator
• Bracket Global: collaborator

Study Sites (11)

104

Alzenau in Unterfranken, Germany

Location

106

Aschaffenburg, Germany

Location

105

Berlin, Germany

Location

107

Böblingen, Germany

Location

101

Cologne, Germany

Location

111

Düsseldorf, Germany

Location

109

Erbach im Odenwald, Germany

Location

110

Essen, Germany

Location

102

Karlstadt am Main, Germany

Location

103

Stuttgart, Germany

Location

108

Würzburg, Germany

Location

Related Publications (1)

• Elshoff JP, Bauer L, Goldammer N, Oortgiesen M, Pesch H, Timmermann L. Randomized, double-blind, crossover study of the adhesiveness of two formulations of rotigotine transdermal patch in patients with Parkinson's disease. Curr Med Res Opin. 2018 Jul;34(7):1293-1299. doi: 10.1080/03007995.2018.1430559. Epub 2018 Feb 20.

  PMID: 29461870 DERIVED

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Parkinson Disease

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: UCB (Study Director)
• Organization: UCB Clinical Trial Call Center

+1 887 822 9493

Study Officials

• UCB Clinical Trial Call Center

  UCB Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 3, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 2, 2015
• Results First Posted: November 2, 2015

Record last verified: 2015-10

Locations

DE (11)