Back to resultsA Study of LY03003 in Patients With Early-stage Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Rotigotine, extended-release microspheres
Placebo, extended-release microspheres
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, LY03003
Eligibility Criteria
Inclusion Criteria:
- Patient had Parkinson's Disease that meet the clinical diagnostic criteria of the brain bank of the Parkinson's Disease Association of the United Kingdom.
- Patient was Hoehn & Yahr stage ≤3 (excluding stage 0) ;
- Patient was male or female aged 18 to 75 years;
- Patient had a Mini Mental State Examination (MMSE) score of ≥25;
- Patient had a Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III) of ≤30 at Screening.
- Patient who signed the informed consent form volunteered to participate in this clinical trial and could cooperate with the prescribed inspections.
Exclusion Criteria:
- Patient had a history of pallidotomy, thalamotomy, deep brain stimulation, or fetal tissue transplant;
- Patient had dementia, schizophrenia or hallucinations, or clinically significant depression;
- Patient had a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or presence of suicidal tendency in the past year;
- Patient had a history of orthostatic hypotension.
- Patient had received therapy with a dopamine (DA) agonist either concurrently or had done so within 28 days prior to the Screening;
- Patient had received therapy with 1 of the following drugs either concurrently or within 28 days prior to Screening: monoamine oxidase B (MAO-B) inhibitors (e.g., pargyline, selegiline), DA releasing agents (e.g., amphetamine), reserpine, DA-antagonists (e.g., metoclopramide), neuroleptics, or other medications that may interact with DA function;
- Patient was currently (at the time of Screening) receiving central nervous system active therapy (e.g., sedatives, hypnotics, antidepressants, anxiolytics), unless the dose had been stable for at least 28 days prior to Screening Visit and was likely to remain stable for the duration of the study;
- Patient had a current diagnosis of epilepsy, had a history of seizures as an adult within 1 year prior to Screening, had a history of stroke or transient ischemic attack within 3 months prior to Screening;
- Patient had a history of known intolerance/hypersensitivity to non-dopaminergic antiemetics, such as domperidone, ondansetron, tropisetron;
- Patient had any other clinically relevant hepatic, renal, and cardiac dysfunction, or laboratory abnormality, which would have, in the judgment of the Investigator, interfered with the patient's ability to participate in the study;
- Patient had a history of allergic to any medication;
- Heavy smoker, alcoholic, drug addict;
- Female patients who were pregnant or were breastfeeding or were of childbearing potential without adequate contraception;
- Patient who was inappropriate to participant in the study in the judgment of the Investigator.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LY03003
Placebo
Arm Description
Outcomes
Primary Outcome Measures
LY03003 concentration in plasma
Secondary Outcome Measures
Frequency of adverse events
Adverse events to evaluate the safety and tolerability of LY03003
Change from baseline to the end of the treatment period in the Unified Parkinson's Disease Rating Scale (UPDRS) part (Ⅲ) Total Score
The Unified Parkinson´s Disease Rating Scale Part Ⅲ is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 (Best score possible) to 108 (Worst score possible).
Full Information
NCT ID
NCT04044547
First Posted
July 30, 2019
Last Updated
August 2, 2019
Sponsor
Luye Pharma Group Ltd.
Collaborators
Beijing Bozhiyin T&S Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04044547
Brief Title
A Study of LY03003 in Patients With Early-stage Parkinson's Disease
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
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 22, 2013 (Actual)
Primary Completion Date
February 26, 2014 (Actual)
Study Completion Date
June 11, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Luye Pharma Group Ltd.
Collaborators
Beijing Bozhiyin T&S Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
This study is to characterize the pharmacokinetics and to evaluate the safety as well as tolerability of LY03003 following multiple escalating intramuscular injections
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson disease, LY03003
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY03003
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rotigotine, extended-release microspheres
Intervention Description
Four stable dose levels of LY03003 at 14, 28, 42 and 56 mg will be evaluated. For each dose level, the stable dose will be administered once a week for consecutive 5 weeks. To improve patient's tolerability, dose upward titration will be applied to 28, 42 and 56 mg dose groups according to the following schedule:
Patients to be enrolled to 14 mg dose group will receive 14 mg for 5 consecutive weeks.
Patients to be enrolled to 28 mg dose group will receive 14 mg in the first week and then 28 mg in the next 5 weeks.
Patients to be enrolled to 42 mg dose group will receive 14 mg in the first week, 28 mg in the second week and then 42 mg in the next 5 weeks.
Patients to be enrolled to 56 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week and then 56 mg in the next 5 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo, extended-release microspheres
Intervention Description
Four stable dose levels of placebo at 14, 28, 42 and 56 mg will be evaluated. For each dose level, the stable dose will be administered once a week for consecutive 5 weeks. To improve patient's tolerability, dose upward titration will be applied to 28, 42 and 56 mg dose groups according to the following schedule:
Patients to be enrolled to 14 mg dose group will receive 14 mg for 5 consecutive weeks.
Patients to be enrolled to 28 mg dose group will receive 14 mg in the first week and then 28 mg in the next 5 weeks.
Patients to be enrolled to 42 mg dose group will receive 14 mg in the first week, 28 mg in the second week and then 42 mg in the next 5 weeks.
Patients to be enrolled to 56 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week and then 56 mg in the next 5 weeks.
Primary Outcome Measure Information:
Title
LY03003 concentration in plasma
Time Frame
Days 1, 2, 4, 6, 8, 15, 22, 29, 30, 32, 34, 36, 38, 40, 43, and day 50
Secondary Outcome Measure Information:
Title
Frequency of adverse events
Description
Adverse events to evaluate the safety and tolerability of LY03003
Time Frame
From screening up to day 50
Title
Change from baseline to the end of the treatment period in the Unified Parkinson's Disease Rating Scale (UPDRS) part (Ⅲ) Total Score
Description
The Unified Parkinson´s Disease Rating Scale Part Ⅲ is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 (Best score possible) to 108 (Worst score possible).
Time Frame
screening, baseline and day 29 and Day 50
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient had Parkinson's Disease that meet the clinical diagnostic criteria of the brain bank of the Parkinson's Disease Association of the United Kingdom.
Patient was Hoehn & Yahr stage ≤3 (excluding stage 0) ;
Patient was male or female aged 18 to 75 years;
Patient had a Mini Mental State Examination (MMSE) score of ≥25;
Patient had a Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III) of ≤30 at Screening.
Patient who signed the informed consent form volunteered to participate in this clinical trial and could cooperate with the prescribed inspections.
Exclusion Criteria:
Patient had a history of pallidotomy, thalamotomy, deep brain stimulation, or fetal tissue transplant;
Patient had dementia, schizophrenia or hallucinations, or clinically significant depression;
Patient had a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or presence of suicidal tendency in the past year;
Patient had a history of orthostatic hypotension.
Patient had received therapy with a dopamine (DA) agonist either concurrently or had done so within 28 days prior to the Screening;
Patient had received therapy with 1 of the following drugs either concurrently or within 28 days prior to Screening: monoamine oxidase B (MAO-B) inhibitors (e.g., pargyline, selegiline), DA releasing agents (e.g., amphetamine), reserpine, DA-antagonists (e.g., metoclopramide), neuroleptics, or other medications that may interact with DA function;
Patient was currently (at the time of Screening) receiving central nervous system active therapy (e.g., sedatives, hypnotics, antidepressants, anxiolytics), unless the dose had been stable for at least 28 days prior to Screening Visit and was likely to remain stable for the duration of the study;
Patient had a current diagnosis of epilepsy, had a history of seizures as an adult within 1 year prior to Screening, had a history of stroke or transient ischemic attack within 3 months prior to Screening;
Patient had a history of known intolerance/hypersensitivity to non-dopaminergic antiemetics, such as domperidone, ondansetron, tropisetron;
Patient had any other clinically relevant hepatic, renal, and cardiac dysfunction, or laboratory abnormality, which would have, in the judgment of the Investigator, interfered with the patient's ability to participate in the study;
Patient had a history of allergic to any medication;
Heavy smoker, alcoholic, drug addict;
Female patients who were pregnant or were breastfeeding or were of childbearing potential without adequate contraception;
Patient who was inappropriate to participant in the study in the judgment of the Investigator.
12. IPD Sharing Statement
Learn more about this trial
A Study of LY03003 in Patients With Early-stage Parkinson's Disease
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