Clinical trial NCT04044547: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Keywords: Parkinson disease
LY03003
Lead sponsor: Luye Pharma Group Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Beijing Bozhiyin T&S Co., Ltd.
First posted: 2019-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: LY03003 concentration in plasma
timeFrame: Days 1, 2, 4, 6, 8, 15, 22, 29, 30, 32, 34, 36, 38, 40, 43, and day 50
Secondary outcomes:
measure: Frequency of adverse events
timeFrame: From screening up to day 50
measure: Change from baseline to the end of the treatment period in the Unified Parkinson's Disease Rating Scale (UPDRS) part (Ⅲ) Total Score
timeFrame: screening, baseline and day 29 and Day 50
Other outcomes:
Locations:
Study officials:
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