Clinical Trial to Investigate Patch Adhesion of Rotigotine Containing Patches in Patients With Parkinson's Disease

NCT06247410 | Completed Phase 2

• 2 other identifiers: 1402rot20ct2021-000867-65
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 8

Brief Summary

The investigational medicinal product (IMP) to be tested in the clinical trial (Rotigotine (ROT)-Transdermal System (TDS) (8 mg/24 h)), which is subject to this submission, was designed as a generic of Neupro® 8 mg/24 h, which is marketed in the European Union since 2006 (date of first authorisation is 2006, date of renewal of the authorisation is 2016) and serves as Reference product. It is the intention of this clinical trial to assess patch adhesion properties of the newly developed rotigotine patch and the marketed Reference product Neupro® 8 mg/24 h after multiple patch applications.

Conditions

Parkinson Disease

Keywords

Rotigotine; Rotigotine Patch; Patch Adhesion; Local Tolerability

Outcome Measures

Primary Outcomes (2)

• Assessment of patch adhesion properties of the Test product in patients diagnosed with idiopathic Parkinson's disease at the end of the dosing interval

  Patch adhesion will be assessed for Test/ Reference 5 min and 23 h 55 min after patch application by trained observers. Area(s) detached will be drawn on transparent films of identical size and shape as the patch in question by the trained observer. As suggested by the Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1), June 2015, patch adhesion will be measured by means of the percentage of area that remains adhered at the end of the dosing interval. Additionally, the patch adhesion will be documented by taking photos at the time point of intended patch adhesion assessment of the patch and surrounding area. The following scores and affiliated percentages for the relative area still in tight contact with the skin will be used in order to quantify the patch adhesion: 0 = ≥ 90% adhered 1. = ≥ 80% adhered 2. = ≥ 70% adhered 3. = ≥ 60% adhered 4. = ≥ 50% adhered 5. = \< 50% adhered or patch completely off the skin.

  24 hours

• Comparative assessment of patch adhesion properties of the Test vs. Reference product in patients diagnosed with idiopathic Parkinson's disease at the end of the dosing interval

  Patch adhesion will be assessed for Test/ Reference 5 min and 23 h 55 min after patch application by trained observers. Area(s) detached will be drawn on transparent films of identical size and shape as the patch in question by the trained observer. As suggested by the Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1), June 2015, patch adhesion will be measured by means of the percentage of area that remains adhered at the end of the dosing interval. Additionally, the patch adhesion will be documented by taking photos at the time point of intended patch adhesion assessment of the patch and surrounding area. The following scores and affiliated percentages for the relative area still in tight contact with the skin will be used in order to quantify the patch adhesion: 0 = ≥ 90% adhered 1. = ≥ 80% adhered 2. = ≥ 70% adhered 3. = ≥ 60% adhered 4. = ≥ 50% adhered 5. = \< 50% adhered or patch completely off the skin.

  24 hours

Secondary Outcomes (2)

• Skin tolerability of Test and Reference based on standardised assessment of Adverse Events of Special Interest

  24 hours

• Descriptive characterisation of safety and tolerability of the investigational medicinal products (IMPs) in the trial population

  4 days

Study Arms (2)

Sequence: Reference-Test-Reference-Test (RTRT)

OTHER

Once daily patch application of one patch of Test or Reference over 4 days, i.e. a total of 4 alternating applications with RTRT sequence. Each patch remains applied for 24 h. Treatments may be directly switched without washout phase. Period 1: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application Period 2: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application Period 3: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application Period 4: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application

Drug: Rotigotine 8Mg/24Hrs Patch

Sequence: Test-Refrence-Test-Reference

OTHER

Once daily patch application of one patch of Test or Reference over 4 days, i.e. a total of 4 alternating applications with TRTR sequence. Each patch remains applied for 24 h. Treatments may be directly switched without washout phase. Period 1: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application Period 2: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application Period 3: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application Period 4: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application

Drug: Rotigotine 8Mg/24Hrs Patch

Interventions

Rotigotine 8Mg/24Hrs Patch DRUG

Once daily patch application of one Rotigotine 8Mg/24Hrs Patch (Test or Reference) over 4 days

Sequence: Reference-Test-Reference-Test (RTRT); Sequence: Test-Refrence-Test-Reference

Eligibility Criteria

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

You may qualify if:

• ethnic origin: Caucasian
• age: 18 years or older
• diagnosis of idiopathic Parkinson's disease
• administration of a stable dose of at least 8 mg/24 h rotigotine including use of an 8 mg/24 h patch for at least 2 weeks prior to enrolment
• agreement to refrain from swimming, bathing or using a sauna on the assessment days
• written informed consent obtained, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the patients participating in the clinical trial

You may not qualify if:

• Safety concerns
• existing and/or history of significant skin hypersensitivity to adhesives or other transdermal products
• existing and/or history of dermatitis (eczema; excluding seborrheic skin by Parkinson's disease)
• existing and/or history of psoriasis
• existing and/or history of an active skin disease which interferes with the rotigotine patch application according to the investigator's assessment
• history of or current drug or alcohol dependence
• existing medical condition or psychiatric condition which, in the opinion of the investigator, could jeopardize or compromise the patient's well-being or ability to participate in this study
• lifetime history of suicide attempt
• suicidal ideation in the past 6 months
• administration of any investigational medicinal product during the last 2 months prior to individual enrolment of the patient
• diagnosis of COVID-19 within the last 14 days prior to individual enrolment of the patient
• contact to persons in foreign risk regions as defined by the Robert Koch Institute within the last 14 days prior to individual enrolment of the patient
• known direct contact with insufficient protection to persons with diagnosis of COVID-19 within the last 14 days prior to individual enrolment upon reporting of the patient
• For female patients with childbearing potential only:
• positive pregnancy test at screening examination

Sponsors & Collaborators

• SocraTec R&D GmbH: lead
• SocraMetrics GmbH: collaborator
• Luye Pharma Group Ltd.: collaborator

Study Sites (8)

Universitätsklinikum Ulm Neur. Studienzentrale im RKU

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Parkinson-Klinik Ortenau GmbH & Co. KG

Wolfach, Baden-Wurttemberg, 77709, Germany

Location

Neuroakademie Alzenau GbR

Alzenau in Unterfranken, Bavaria, 63755, Germany

Location

Curiositas ad Sanum Studien- und Beratungs GmbH Innklinikum Haag i.OB

Haag in Oberbayern, Bavaria, 83527, Germany

Location

Curiositas ad Sanum Studien- und Beratungs GmbH

München, Bavaria, 80331, Germany

Location

Neurologisches Fachkrankenhaus für Bewegungsstörungen/ Parkinson

Beelitz-Heilstätten, Brandenburg, 14547, Germany

Location

Gertrudis-Klinik Parkinson-Zentrum GmbH

Leun, Hesse, 35638, Germany

Location

Praxis für Neurologie Dr. med. Christian Oehlwein

Gera, Thuringia, 07551, Germany

Location

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

Study Officials

• Wolfgang Jost, Prof. Dr med

  Parkinson-Klinik Ortenau GmbH & Co KG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 7, 2024
• Study Start: August 23, 2021
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8)