A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
LY03003(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:
- Informed consent must be given to the trial and written informed consent must be voluntarily signed, good communication with the investigator and compliance with all requirements of the clinical trial (planned visits, laboratory tests and other procedures);
- Age ≥30 years old, regardless of gender;
- The subject has had primary Parkinson's disease for less than 5 years, and the diagnosis is based on the main symptom -- motor delay plus at least 1 symptom: quiescence tremor, myotonia, and no other known or suspected cause of Parkinson's disease;
- Hoehn-yahr grading ≤3 (excluding 0);
- Brief mental state examination (MMSE) ≥25 points;
- Unified Parkinson disease rating scale (UPDRS) motor score (part Ⅲ) 10 or higher;
- If the subjects are receiving anticholinergic drugs (such as benzalkonium tropic, benzene hai suo, diethyl promethazine, its organism and than pp board), MAO - B inhibitors (e.g., company to gillan, LeiSha gillan), NMDA antagonists, such as amantadine treatment, must dose before baseline stability at least 28 days, and maintain the dose treatment during the study period
- Women of childbearing age (defined as women who have not undergone surgical sterilization or less than 1 year after menopause) or male subjects agree to use reliable contraceptives (oral contraceptives, condom use, abstinence, etc.) throughout the study period (until the end of the study), and pregnancy outcomes were negative for women of childbearing age at screening and baseline.
Exclusion Criteria:
- History of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplantation
- Dementia, active mental illness or hallucination, major depression
- Those who received dopamine receptor agonists within 28 days before baseline
- Patients receiving levodopa preparation (including levodopa compound preparation) within 28 days before baseline, or levodopa preparation after diagnosis for more than 6 months
- Patients receiving any of the following drugs within 28 days before baseline: amphetamine, metoclopramide, α-methyldopa, antipsychotics, MAO-Ainhibitors, flunarizine, reserpine, methylphenidate, budesonide, etc
- Active central nervous system drugs (such as sedatives, hypnotics, antidepressants, and antianxiety drugs) are under treatment, except those who have maintained a stable dose for at least 28 days before the baseline (visit 2) and may remain stable during the study period
- Atypical Parkinson's disease symptoms caused by taking drugs (such as metoclopramide, flunarizine), hereditary metabolic diseases of nervous system (such as Wilson's disease), encephalitis, cerebrovascular diseases or degenerative diseases (such as progressive supranuclear paralysis)
- Have a history of epilepsy, or have a history of stroke or transient cerebral ischemia within 1 year before the visit
- Those who are intolerant or allergic to the following antiemetic drugs, such as domperidone, trimethoxybenzamide, ondansetron, tropisetron, granisetron and glinbromide
- Patients with clinically significant abnormal liver function were defined as total bilirubin > 1.5 times of the upper limit of the reference value range or ALT or ast > 2 times of the upper limit of the reference value range
- Patients with clinically significant renal dysfunction (serum creatinine > 2.0 mg / dl [> 177 μ mol / l])
- Patients with uncontrollable or important cardiovascular diseases, including congestive heart failure of NYHA grade II or above, unstable angina pectoris, myocardial infarction within 6 months before the first administration of trial drug, or arrhythmia requiring treatment at the time of screening
- At screening, QTc interval: male > 450ms, female > 460ms
- Patients with a history of orthostatic hypotension, or those with SBP ≥ 20mmhg or DBP ≥ 10mmhg at screening (visit 1) and baseline (visit 2) when switching from supine position to upright position for 1 or 3 minutes; or those with SBP < 105mmhg at visit 1 and visit 2;
- Subjects with evidence of impulse control disorder (ICD) during screening (visit 1);
- A history of suicide attempt (including actual attempt, interruption or failure of attempt) or suicidal ideation in the past 6 months were defined as those who answered "yes" to question 4 or question 5 of the Columbia suicide severity rating scale (c-ssrs) during screening (visit 1);
- Patients with history of narcolepsy;
- Those who had a history of alcoholism, drug abuse and drug abuse in the past five years (visit 1) were screened. Alcoholism was defined as drinking more than 14 units of alcohol per week (1 unit = 360 ml beer or 45 ml alcohol with 40% alcohol content or 150 ml wine);
- Patients with malignant tumor within 5 years before screening were excluded from cervical carcinoma in situ, skin basal cell or squamous cell carcinoma, local prostate cancer after radical operation and breast intraductal carcinoma in situ after radical operation;
- Pregnant or lactating women;
- The patients who had participated in the rotigotine test were intolerable or ineffective;
- Allergic constitution (allergic to two or more drugs or foods) or known to be allergic to rotigotine or rotigotine microspheres;
- Those who have participated in clinical trials of other drugs within 3 months before screening;
- Other clinically significant medical status, mental status or laboratory abnormalities judged by the researcher may interfere with the subject's ability to participate in the study.
Sites / Locations
- Xuanwu Hospital Capital Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LY03003
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline to the end of the treatment period in the Unified Parkinson's Disease Rating Scale(UPDRS)part(Ⅱ+Ⅲ)Total Score
Secondary Outcome Measures
The proportion of patients whose total UPDRS decreased by 20、25、30percent or mors
UPDRS scale part Ⅱchanges relative to the baseline
UPDRS scale part Ⅲchanges relative to the baseline
Changes in SI scores in the Total Clinical Efficacy Rating Scale (CGI) relative to baseline,the scores of GI and EI
To clarify the changes in PDQ-8 questionnaire scores relative to baseline
To clarify the changes in PDSS questionnaire scores relative to baseline
To clarify the changes in BDI-Ⅱquestionnaire scores relative to baseline
Full Information
NCT ID
NCT04571164
First Posted
September 21, 2020
Last Updated
May 5, 2023
Sponsor
Luye Pharma Group Ltd.
Collaborators
Parexel
1. Study Identification
Unique Protocol Identification Number
NCT04571164
Brief Title
A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD
Official Title
A Multi-centre,Randomized,Double-blind,Placebo Parallel Controlled Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 11, 2020 (Actual)
Primary Completion Date
March 17, 2022 (Actual)
Study Completion Date
September 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Luye Pharma Group Ltd.
Collaborators
Parexel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is to evaluate the effictiveness and safety 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 Disease
Keywords
parkinson disease, LY03003
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
294 (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)
LY03003(Rotigotine,extended-release microspheres)
Intervention Description
During the intervention, the initial dose was 14mg, and then was incremented in weekly units, 14mg each time, until the maximum dose of 56mg set in this study was reached 4 weeks after titration, the optimal therapeutic dose or the maximum tolerated dose was entered into the dosing maintenance period. After entering the maintenance period, no dose adjustment was performed, and the stable dose was maintained for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo,extended-release microspheres
Intervention Description
During the intervention,the initial does was 14mg,and then was incremented in weekly units,14mg each time,until the maximum does of 56mg set in this study was reached 4 weeks after titration,the optimal therapeutic does or the maximum tolerated does was entered into the dosing maintenance period.After entering the maintenance period,no does adjustment was performed,and the stable does was maintained for 24 weeks.
Primary Outcome Measure Information:
Title
Change from baseline to the end of the treatment period in the Unified Parkinson's Disease Rating Scale(UPDRS)part(Ⅱ+Ⅲ)Total Score
Time Frame
From baseline to the end of the double-blind dose maintenance period at 24weeks
Secondary Outcome Measure Information:
Title
The proportion of patients whose total UPDRS decreased by 20、25、30percent or mors
Time Frame
From baseline to the end of the double-blind dose maintenance period at 24weeks
Title
UPDRS scale part Ⅱchanges relative to the baseline
Time Frame
From baseline to the end of the double-blind dose maintenance period at 24weeks
Title
UPDRS scale part Ⅲchanges relative to the baseline
Time Frame
From baseline to the end of the double-blind dose maintenance period at 24weeks
Title
Changes in SI scores in the Total Clinical Efficacy Rating Scale (CGI) relative to baseline,the scores of GI and EI
Time Frame
From baseline to the end of the double-blind dose maintenance period at 24weeks
Title
To clarify the changes in PDQ-8 questionnaire scores relative to baseline
Time Frame
From baseline to the end of the double-blind dose maintenance period at 24weeks
Title
To clarify the changes in PDSS questionnaire scores relative to baseline
Time Frame
From baseline to the end of the double-blind dose maintenance period at 24weeks
Title
To clarify the changes in BDI-Ⅱquestionnaire scores relative to baseline
Time Frame
From baseline to the end of the double-blind dose maintenance period at 24weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent must be given to the trial and written informed consent must be voluntarily signed, good communication with the investigator and compliance with all requirements of the clinical trial (planned visits, laboratory tests and other procedures);
Age ≥30 years old, regardless of gender;
The subject has had primary Parkinson's disease for less than 5 years, and the diagnosis is based on the main symptom -- motor delay plus at least 1 symptom: quiescence tremor, myotonia, and no other known or suspected cause of Parkinson's disease;
Hoehn-yahr grading ≤3 (excluding 0);
Brief mental state examination (MMSE) ≥25 points;
Unified Parkinson disease rating scale (UPDRS) motor score (part Ⅲ) 10 or higher;
If the subjects are receiving anticholinergic drugs (such as benzalkonium tropic, benzene hai suo, diethyl promethazine, its organism and than pp board), MAO - B inhibitors (e.g., company to gillan, LeiSha gillan), NMDA antagonists, such as amantadine treatment, must dose before baseline stability at least 28 days, and maintain the dose treatment during the study period
Women of childbearing age (defined as women who have not undergone surgical sterilization or less than 1 year after menopause) or male subjects agree to use reliable contraceptives (oral contraceptives, condom use, abstinence, etc.) throughout the study period (until the end of the study), and pregnancy outcomes were negative for women of childbearing age at screening and baseline.
Exclusion Criteria:
History of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplantation
Dementia, active mental illness or hallucination, major depression
Those who received dopamine receptor agonists within 28 days before baseline
Patients receiving levodopa preparation (including levodopa compound preparation) within 28 days before baseline, or levodopa preparation after diagnosis for more than 6 months
Patients receiving any of the following drugs within 28 days before baseline: amphetamine, metoclopramide, α-methyldopa, antipsychotics, MAO-Ainhibitors, flunarizine, reserpine, methylphenidate, budesonide, etc
Active central nervous system drugs (such as sedatives, hypnotics, antidepressants, and antianxiety drugs) are under treatment, except those who have maintained a stable dose for at least 28 days before the baseline (visit 2) and may remain stable during the study period
Atypical Parkinson's disease symptoms caused by taking drugs (such as metoclopramide, flunarizine), hereditary metabolic diseases of nervous system (such as Wilson's disease), encephalitis, cerebrovascular diseases or degenerative diseases (such as progressive supranuclear paralysis)
Have a history of epilepsy, or have a history of stroke or transient cerebral ischemia within 1 year before the visit
Those who are intolerant or allergic to the following antiemetic drugs, such as domperidone, trimethoxybenzamide, ondansetron, tropisetron, granisetron and glinbromide
Patients with clinically significant abnormal liver function were defined as total bilirubin > 1.5 times of the upper limit of the reference value range or ALT or ast > 2 times of the upper limit of the reference value range
Patients with clinically significant renal dysfunction (serum creatinine > 2.0 mg / dl [> 177 μ mol / l])
Patients with uncontrollable or important cardiovascular diseases, including congestive heart failure of NYHA grade II or above, unstable angina pectoris, myocardial infarction within 6 months before the first administration of trial drug, or arrhythmia requiring treatment at the time of screening
At screening, QTc interval: male > 450ms, female > 460ms
Patients with a history of orthostatic hypotension, or those with SBP ≥ 20mmhg or DBP ≥ 10mmhg at screening (visit 1) and baseline (visit 2) when switching from supine position to upright position for 1 or 3 minutes; or those with SBP < 105mmhg at visit 1 and visit 2;
Subjects with evidence of impulse control disorder (ICD) during screening (visit 1);
A history of suicide attempt (including actual attempt, interruption or failure of attempt) or suicidal ideation in the past 6 months were defined as those who answered "yes" to question 4 or question 5 of the Columbia suicide severity rating scale (c-ssrs) during screening (visit 1);
Patients with history of narcolepsy;
Those who had a history of alcoholism, drug abuse and drug abuse in the past five years (visit 1) were screened. Alcoholism was defined as drinking more than 14 units of alcohol per week (1 unit = 360 ml beer or 45 ml alcohol with 40% alcohol content or 150 ml wine);
Patients with malignant tumor within 5 years before screening were excluded from cervical carcinoma in situ, skin basal cell or squamous cell carcinoma, local prostate cancer after radical operation and breast intraductal carcinoma in situ after radical operation;
Pregnant or lactating women;
The patients who had participated in the rotigotine test were intolerable or ineffective;
Allergic constitution (allergic to two or more drugs or foods) or known to be allergic to rotigotine or rotigotine microspheres;
Those who have participated in clinical trials of other drugs within 3 months before screening;
Other clinically significant medical status, mental status or laboratory abnormalities judged by the researcher may interfere with the subject's ability to participate in the study.
Facility Information:
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
Country
China
12. IPD Sharing Statement
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A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD
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