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

NCT04183634 | Terminated Phase 1

• 1 other identifier: 2019-06-TTS-10
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

adhesiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of patients with cold flow

  24 hours in each Treatment Period

• Number of patients with patch movement/displacement

  24 hours in each Treatment Period

• Number of patients with patch wrinkling

  24 hours in each Treatment Period

• Number of patients with patch residue formation

  24 hours in each Treatment Period

Study Arms (2)

Period 1: Rotigotine TTS (Test) - Period 2: Neupro (Reference)

EXPERIMENTAL

For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h

Drug: Rotigotine TTS (Test); Drug: Neupro (Reference)

Period 1: Neupro (Reference) - Period 2: Rotigotine TTS (Test)

ACTIVE COMPARATOR

For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h

Drug: Rotigotine TTS (Test); Drug: Neupro (Reference)

Interventions

Rotigotine TTS (Test) DRUG

Transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24.

Period 1: Neupro (Reference) - Period 2: Rotigotine TTS (Test); Period 1: Rotigotine TTS (Test) - Period 2: Neupro (Reference)

Neupro (Reference) DRUG

Neupro®: transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24 h.

Period 1: Neupro (Reference) - Period 2: Rotigotine TTS (Test); Period 1: Rotigotine TTS (Test) - Period 2: Neupro (Reference)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sandoz: lead

Study Sites (1)

Sandoz Investigative Site

Hamburg, 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

• Sandoz

  Sandoz

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 3, 2019
• Study Start: December 3, 2019
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)