Status:
COMPLETED
A Multiple Ascending Dose Study With LY03003 in Patients With Early-stage Parkinson's Disease
Lead Sponsor:
Luye Pharma Group Ltd.
Collaborating Sponsors:
Beijing Bozhiyin T&S Co., Ltd.
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study is to evaluate the safety and tolerability and to characterize the pharmacokinetics of multiple ascending dose (MAD) of LY03003 following intramuscular injections.
Eligibility Criteria
Inclusion
- 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 ≥10 but ≤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
- Patient had 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 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 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 had a history of orthostatic hypotension with a decrease of ≥20 mmHg in systolic blood pressure (SBP) or ≥10 mmHg in diastolic blood pressure when changing from the supine to the standing position and keeping in the standing position for 3 minutes;
- 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 clinically significant liver dysfunction (which defined as total bilirubin above the upper limit of normal range, or alanine transferase (ALT) and / or aspartate transferase (AST) 2 times higher than the upper limit of normal range);
- Patient had clinically significant renal insufficiency (serum creatinine \>2.0 mg/dL \[ \>178 μmol/L\]);
- Patient had clinically significant cardiac insufficiency and/or had myocardial infarction in the past 12 months;
- 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; male patients who cannot take adequate contraception during the study;
- Patient who was inappropriate to participant in the study in the judgment of the Investigator.
Key Trial Info
Start Date :
October 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04045678
Start Date
October 10 2017
End Date
June 21 2019
Last Update
September 22 2020
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Chinese PLA General Hospital
Beijing, China
2
Xuanwu Hospital Capital Medical University
Beijing, China
3
Shengjing Hospital of China Medical University
Shenyang, China