Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's Disease

• ClinicalTrials.gov Identifier: NCT02728947
• Recruitment Status: Completed
• First Posted: April 5, 2016
• Last Update Posted: December 5, 2016
• Sponsor: Luye Pharma Group Ltd.
• Information provided by (Responsible Party): Luye Pharma Group Ltd.

Study Description

Brief Summary:

To study the profile of Neupro patch administrated at 2 mg, 4 mg, 6 mg and 8 mg/day weekly in patients with early-stage Parkinson's disease

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease	Drug: ROTIGOTINE	Phase 1

Detailed Description:

A single group and open-label study to evaluate pharmacokinetic profile of Neupro patch administrated at 2 mg, 4 mg, 6 mg and 8 mg/day weekly in patients with early-stage Parkinson's disease

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single Group and Open-label Study to Evaluate Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's Disease
• Study Start Date: May 2016
• Actual Primary Completion Date: August 2016
• Actual Study Completion Date: September 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 2mg; 1 week on 2mg/24 hr patch	Drug: ROTIGOTINE; 1 week at each dose; Other Name: Neupro
Active Comparator: 4mg; 1 week on 4mg/24hr patch	Drug: ROTIGOTINE; 1 week at each dose; Other Name: Neupro
Active Comparator: 6mg; 1 week on 6mg/24hr patch	Drug: ROTIGOTINE; 1 week at each dose; Other Name: Neupro
Active Comparator: 8mg; 1 week on 8mg/24hr patch	Drug: ROTIGOTINE; 1 week at each dose; Other Name: Neupro

Outcome Measures

Primary Outcome Measures :

1. CMax of ROTIGOTINE [ Time Frame: 38 Days ]
   PK parameters Cmax-ss

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Patient who is capable of giving informed consent and complying with study procedures
2. Patient who has Idiopathic Parkinson's Disease defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, or impairment of postural reflexes, and without any other known or suspected cause of Parkinsonism
3. Patient who is Hoehn & Yahr stage less than or equal to 3
4. Patient who is male or female aged greater than or equal to 18 years at Screening
5. Patient who has a Mini Mental State Examination (MMSE) score of greater than or equal to 25
6. Patient who has a Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III) of greater than or equal to 10 but less then or equal to 30 at Screening

Exclusion Criteria:

1. Patient who has atypical Parkinson's syndrome(s) due to drugs (e.g., metoclopramide, flunarizine), metabolic neurogenetic disorders (e.g., Wilson's Disease), encephalitis, cerebrovascular disease, or degenerative disease (e.g., progressive Supranuclear Palsy)
2. Patient who has a history of pallidotomy, thalamotomy, deep brain stimulation, or fetal tissue transplant
3. Patient who has dementia, active psychosis or hallucinations, or clinically significant depression
4. Patient who 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
5. Patient who has a history of symptomatic orthostatic hypotension with a decrease of less than or equal to 20 mmHg in systolic blood pressure (SBP) or great than or equal to 10 mmHg in diastolic blood pressure when changing from supine to standing position after having been at supine position for at least 5 minutes within 28 days prior to the Screening Visit, or SBP less than 105 mmHg at study entry, or reports clinical signs of clinically significant orthostatic hypotension within 28 days prior to the Screening Visit.
6. Patient who is receiving therapy with a dopamine agonist either concurrently or has done so within 28 days prior to the Screening
7. Patient who is receiving therapy with 1 of the following drugs either concurrently or within 28 days prior to screening: MAO-B inhibitors, DA releasing agents, DA modulating agent, DA antagonists, neuroleptics, or other medications that may interact with DA function.
8. Patient who is currently receiving central nervous system active therapy (e.g., sedatives, hypnotics, antidepressants, anxiolytics), unless the dose has been stable for at least 28 days prior to Screening Visit and is likely to remain stable for the duration of the study. Patients should not take those medications within 8 hours prior to clinical visits
9. Patient who has a current diagnosis of epilepsy, has a history of seizures as an adult, has a history of stroke, or has had a transient ischemic attack within 1 year prior to Screening
10. Patient who has a history of known intolerance/hypersensitivity to non-dopaminegic antiemetics, such as domperidone, ondansetron, tropisetron, and glycopyrrolate
11. Patient who has any other clinically relevant hepatic, renal and cardiac dysfunction, or other medical condition or laboratory abnormality including abnormal plasma magnesium level, which would in the judgment of the investigator, interfere with the patient's ability to participate in the study
12. Patient who has a history of significant skin hypersensitivity to adhesive or other transdermal preparations or recent unresolved contact Dermatitis
13. Patient with C-reactive protein levels of 2x of upper limit of normal range
14. Female patient who is pregnant or is breastfeeding or is of childbearing potential without adequate contraception.
15. Patient with a positive finding in drug screening test or alcohol test

Contacts and Locations

Locations

United States, California

CNS Network

Long Beach, California, United States, 90806

United States, Florida

MD Clinical

Hallandale Beach, Florida, United States, 33009

United States, Georgia

Atlanta Center for Medical Research

Atlanta, Georgia, United States, 30331

Sponsors and Collaborators

Luye Pharma Group Ltd.

Investigators

• Study Chair: Simon Li, MD; Luye Pharma

More Information

• Responsible Party: Luye Pharma Group Ltd.
• ClinicalTrials.gov Identifier: NCT02728947
• Other Study ID Numbers: LY03003-CT-USA-103
• First Posted: April 5, 2016
• Last Update Posted: December 5, 2016
• Last Verified: December 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Luye Pharma Group Ltd.:

Parkinson's Disease

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Rotigotine; Dopamine Agonists; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs