Pharmacokinetics and Safety Study of LY03003 in Patients With Early-stage Parkinson's Disease (03003MAD)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY03003
Neupro
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinsons
Eligibility Criteria
Inclusion Criteria:
- Subject 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
- Subject is Hoehn & Yahr stage ≤3
- Subject is male or female aged ≥18 years at Screening
- Subject has a Mini Mental State Examination (MMSE) score of ≥25
- Subject has a Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III) of ≥10 but ≤30 at Screening
Exclusion Criteria:
- Subject 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)
- Subject has a history of Pallidotomy, Thalamotomy, deep brain stimulation, or fetal tissue transplant
- Subject has dementia, active psychosis or hallucinations, or clinically significant depression
- Subject 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 (CSSRS) at Screening
- Subject has a history of symptomatic orthostatic hypotension with a decrease of ≥20 mmHg in systolic blood pressure (SBP) or ≥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.
- Subject is receiving therapy with a dopamine agonist (DA) either concurrently or has done so within 28 days prior to the Screening
- Subject 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.
- Subject 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
- Subject 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
- Subject has a history of known intolerance/hypersensitivity to non-dopaminergic antiemetics, such as domperidone, ondansetron, tropisetron, and glycopyrrolate
- Subject 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 subject's ability to participate in the study
- Subject has a history of significant skin hypersensitivity to adhesive or other transdermal preparations or recent unresolved contact Dermatitis (this item is specific for patients to be enrolled to part 2 of this study)
- Subjects with C-reactive protein levels of 2x of upper limit of normal range
- Female subjects who are pregnant or are breastfeeding or are of childbearing potential without adequate contraception.
- Patients with a positive finding in drug screening test or alcohol test
Sites / Locations
- Collaborative Neuroscience Network LLC
- Compass Research LLC
- West Georgia Sleep Disorders Center and Neurology Associates
- Quest Research Institute
- PRA - CRI Lifetree
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
LY03003
Neupro
Neupro PK
Arm Description
4 Stable doses of LY03003 14, 28, 42 and 56 mg
Neupro patch 2 mg/24 hours in the first week, and then be titrated to 4, 6 and 8 mg/24 hours at weekly intervals
Neupro patch 2 mg/24hr in the first week then titrated to 4 and 6mg/24hr
Outcomes
Primary Outcome Measures
Cmax for the Pharmacokinetics (PK) of LY03003
Secondary Outcome Measures
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Preliminary efficacy evaluation will be carried out based on Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III)
Full Information
NCT ID
NCT02055274
First Posted
January 31, 2014
Last Updated
October 20, 2015
Sponsor
Luye Pharma Group Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02055274
Brief Title
Pharmacokinetics and Safety Study of LY03003 in Patients With Early-stage Parkinson's Disease
Acronym
03003MAD
Official Title
A Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Luye Pharma Group Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to characterize the pharmacokinetics (PK) of LY03003 following multiple escalating intramuscular injections, as compared to Neupro patch and to evaluate the safety and tolerability and preliminary efficacy of multiple ascending dose (MAD) of LY03003 following intramuscular injections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinsons
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY03003
Arm Type
Experimental
Arm Description
4 Stable doses of LY03003 14, 28, 42 and 56 mg
Arm Title
Neupro
Arm Type
Active Comparator
Arm Description
Neupro patch 2 mg/24 hours in the first week, and then be titrated to 4, 6 and 8 mg/24 hours at weekly intervals
Arm Title
Neupro PK
Arm Type
Active Comparator
Arm Description
Neupro patch 2 mg/24hr in the first week then titrated to 4 and 6mg/24hr
Intervention Type
Drug
Intervention Name(s)
LY03003
Intervention Type
Drug
Intervention Name(s)
Neupro
Primary Outcome Measure Information:
Title
Cmax for the Pharmacokinetics (PK) of LY03003
Time Frame
5 Weeks
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
5 Weeks
Title
Preliminary efficacy evaluation will be carried out based on Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III)
Time Frame
5 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject 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
Subject is Hoehn & Yahr stage ≤3
Subject is male or female aged ≥18 years at Screening
Subject has a Mini Mental State Examination (MMSE) score of ≥25
Subject has a Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III) of ≥10 but ≤30 at Screening
Exclusion Criteria:
Subject 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)
Subject has a history of Pallidotomy, Thalamotomy, deep brain stimulation, or fetal tissue transplant
Subject has dementia, active psychosis or hallucinations, or clinically significant depression
Subject 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 (CSSRS) at Screening
Subject has a history of symptomatic orthostatic hypotension with a decrease of ≥20 mmHg in systolic blood pressure (SBP) or ≥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.
Subject is receiving therapy with a dopamine agonist (DA) either concurrently or has done so within 28 days prior to the Screening
Subject 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.
Subject 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
Subject 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
Subject has a history of known intolerance/hypersensitivity to non-dopaminergic antiemetics, such as domperidone, ondansetron, tropisetron, and glycopyrrolate
Subject 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 subject's ability to participate in the study
Subject has a history of significant skin hypersensitivity to adhesive or other transdermal preparations or recent unresolved contact Dermatitis (this item is specific for patients to be enrolled to part 2 of this study)
Subjects with C-reactive protein levels of 2x of upper limit of normal range
Female subjects who are pregnant or are breastfeeding or are of childbearing potential without adequate contraception.
Patients with a positive finding in drug screening test or alcohol test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Li
Organizational Affiliation
Luye Pharma Group Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Collaborative Neuroscience Network LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Compass Research LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
West Georgia Sleep Disorders Center and Neurology Associates
City
Douglasville
State/Province
Georgia
ZIP/Postal Code
30134
Country
United States
Facility Name
Quest Research Institute
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
PRA - CRI Lifetree
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
12. IPD Sharing Statement
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Pharmacokinetics and Safety Study of LY03003 in Patients With Early-stage Parkinson's Disease
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