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
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ROTIGOTINE
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- Patient who is capable of giving informed consent and complying with study procedures
- 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
- Patient who is Hoehn & Yahr stage less than or equal to 3
- Patient who is male or female aged greater than or equal to 18 years at Screening
- Patient who has a Mini Mental State Examination (MMSE) score of greater than or equal to 25
- 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:
- 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)
- Patient who has a history of pallidotomy, thalamotomy, deep brain stimulation, or fetal tissue transplant
- Patient who has dementia, active psychosis or hallucinations, or clinically significant depression
- 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
- 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.
- Patient who is receiving therapy with a dopamine agonist either concurrently or has done so within 28 days prior to the Screening
- 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.
- 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
- 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
- Patient who has a history of known intolerance/hypersensitivity to non-dopaminegic antiemetics, such as domperidone, ondansetron, tropisetron, and glycopyrrolate
- 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
- Patient who has a history of significant skin hypersensitivity to adhesive or other transdermal preparations or recent unresolved contact Dermatitis
- Patient with C-reactive protein levels of 2x of upper limit of normal range
- Female patient who is pregnant or is breastfeeding or is of childbearing potential without adequate contraception.
- Patient with a positive finding in drug screening test or alcohol test
Sites / Locations
- CNS Network
- MD Clinical
- Atlanta Center for Medical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
2mg
4mg
6mg
8mg
Arm Description
1 week on 2mg/24 hr patch
1 week on 4mg/24hr patch
1 week on 6mg/24hr patch
1 week on 8mg/24hr patch
Outcomes
Primary Outcome Measures
CMax of ROTIGOTINE
PK parameters Cmax-ss
Secondary Outcome Measures
Full Information
NCT ID
NCT02728947
First Posted
March 31, 2016
Last Updated
December 2, 2016
Sponsor
Luye Pharma Group Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02728947
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Luye Pharma Group Ltd.
4. Oversight
Data Monitoring Committee
No
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2mg
Arm Type
Active Comparator
Arm Description
1 week on 2mg/24 hr patch
Arm Title
4mg
Arm Type
Active Comparator
Arm Description
1 week on 4mg/24hr patch
Arm Title
6mg
Arm Type
Active Comparator
Arm Description
1 week on 6mg/24hr patch
Arm Title
8mg
Arm Type
Active Comparator
Arm Description
1 week on 8mg/24hr patch
Intervention Type
Drug
Intervention Name(s)
ROTIGOTINE
Other Intervention Name(s)
Neupro
Intervention Description
1 week at each dose
Primary Outcome Measure Information:
Title
CMax of ROTIGOTINE
Description
PK parameters Cmax-ss
Time Frame
38 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient who is capable of giving informed consent and complying with study procedures
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
Patient who is Hoehn & Yahr stage less than or equal to 3
Patient who is male or female aged greater than or equal to 18 years at Screening
Patient who has a Mini Mental State Examination (MMSE) score of greater than or equal to 25
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:
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)
Patient who has a history of pallidotomy, thalamotomy, deep brain stimulation, or fetal tissue transplant
Patient who has dementia, active psychosis or hallucinations, or clinically significant depression
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
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.
Patient who is receiving therapy with a dopamine agonist either concurrently or has done so within 28 days prior to the Screening
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.
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
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
Patient who has a history of known intolerance/hypersensitivity to non-dopaminegic antiemetics, such as domperidone, ondansetron, tropisetron, and glycopyrrolate
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
Patient who has a history of significant skin hypersensitivity to adhesive or other transdermal preparations or recent unresolved contact Dermatitis
Patient with C-reactive protein levels of 2x of upper limit of normal range
Female patient who is pregnant or is breastfeeding or is of childbearing potential without adequate contraception.
Patient with a positive finding in drug screening test or alcohol test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Li, MD
Organizational Affiliation
Luye Pharma
Official's Role
Study Chair
Facility Information:
Facility Name
CNS Network
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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