Irritation and Sensitization Potential of Repeat Applications of Rotigotine Patch

NCT02727205 | Completed Phase 1

• 1 other identifier: AC13GP01
• Study Type: interventional
• Target: 260
• Locations: 2 countries
• Sites: 2

Brief Summary

STUDY TITLE: A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat Applications of Rotigotine Transdermal System, 1 mg/24 hr Versus Neupro (Rotigotine Transdermal System), 1 mg/24 hr in Healthy Volunteers TEST DRUG / INVESTIGATIONAL PRODUCT: Rotigotine Transdermal System, 1 mg/24 hr INDICATION STUDIED: Bioequivalence - Irritation and Sensitization STUDY DESIGN:

• Multiple-site, randomized, multiple-application, evaluator-blinded, controlled study
• One-half (½) of the test patch and one-half (½) of the reference patch was applied daily to the same site for each product over a 21 day period followed by a rest phase and a challenge phase

Conditions

Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch

Outcome Measures

Primary Outcomes (2)

• Irritation

  The primary endpoint of cumulative irritation was the measurement of the combined "Dermal response" and "Other Effect" total irritation scores recorded during the 21 day continuous application period (i.e. the total irritation score for a specific subject was the sum of the irritation scores recorded on Days 2 through 22 for each patch type). Because the cumulative irritation scores did not display a normal distribution, the primary analysis was a comparison of the overall median of the observed total irritation score of the Test patch against the Reference patch. The Per Protocol Population for Irritation (PPPI) was used for the primary analysis

  21 days (Induction Phase)

• Sensitization

  The primary analysis of sensitization used the Per Protocol Population for Sensitization (PPPS) and compared the number and percentage (%) of reactions indicating potential sensitization (irritation score greater than or equal to 2 at 48 or 72 hours post-removal, along with the Investigator's assessment) observed with each patch type

  48 and 72 hour post removal of patch after the challenge phase.

Secondary Outcomes (1)

• Adhesion

  21 days (Induction Phase) and 1 day Sensitization Phase

Study Arms (1)

Single Arm

EXPERIMENTAL

One-half (½) of the test patch and one-half (½) of the reference patch (Rotigotine Transdermal System) was applied daily to the same site for each product over a 21 day period followed by a 14 day rest phase and a 48 hour challenge phase.

Drug: Rotigotine Transdermal System

Interventions

Rotigotine Transdermal System DRUG

Also known as: Neupro

Single Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and non-pregnant female volunteers. All subjects were healthy, non-smoking male and female (nonpregnant) volunteers between the ages of 18 and 65, who were demonstrated to be generally healthy by screening medical and medication history, physical examinations, vital signs, 12-lead electrocardiogram (ECG), and FSH levels (if applicable).

You may not qualify if:

• Reported receiving any investigational drug within 30 days prior to Day 1 patch application.
• Reported a clinically significant illness during the 28 days prior to Day 1 patch application (as determined by the Investigator\[s\]).
• Reported a history of allergic response(s) to rotigotine or related drugs.
• Reported a history of sulfite sensitivity.
• Demonstrated a clinically relevant finding, as determined by the clinical Investigator(s), on the screening ECG, such as a second- or third-degree atrioventricular block or complete bundle branch block, or arrhythmias.
• Reported a history of asthma, orthostatic hypotension, dizziness, syncope, or dyskinesia. At the discretion of the Principal Investigator, subjects with a history of asthma or mild asthma not requiring regular treatment could have been included.
• Systolic blood pressure \< 100 or \>145 mmHg or diastolic blood pressure \< 60 or \> 95 mmHg at screening measured in supine position after 5 minutes rest; heart rate \< 50 or \> 100 at screening.
• Reported a history of narrow angle glaucoma.
• Reported the use of monoamine oxidase (MAO) inhibitors, reserpine, methyldopa, antipsychotics, neuroleptics, benzodiazepines, antidepressants, clozapine, olanzapine, quetiapine, metoclopramide, or risperidone within 3 months of enrollment.
• Reported a history of somnolence and/or of falling asleep without warning.
• Reported a history of significant dermatologic diseases or conditions such as atopy, or psoriasis.
• Reported a history of medical conditions known to alter skin appearance or physiologic response (eg diabetes, porphyria).
• Reported a history of significant dermatologic cancers (eg melanoma, squamous cell carcinoma). Basal cell carcinomas that were superficial and did not involve the investigative sites were acceptable.
• Reported a history of conditions that would significantly influence the immune response (e.g. primary or acquired immunodeficiencies such as HIV positive or AIDS, or generalized drug reaction, neoplasms such as lymphoma or leukemia, moderate or severe rheumatoid arthritis or active systemic lupus erythematosus).
• Demonstrated an obvious difference in skin color amongst application sites, presence of a skin condition, excessive hair (subjects that agreed to have their hair clipped short \[not shaved\] prior to patch application were eligible), scar tissue, recent sunburn, tattoo, open sore, body piercing, or branding at the intended sites of application that would interfere with placement of study articles, skin assessment or reactions to drug.

Sponsors & Collaborators

• Inflamax Research Incorporated: lead

Study Sites (2)

Clinical Pharmacology of Miami, Inc.

Miami, Florida, 33014, United States

Location

Inflamax Research Inc.

Mississauga, Ontario, L4W 1A4, Canada

Location

MeSH Terms

Interventions

rotigotine

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: April 4, 2016
• Study Start: August 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 4, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1)