CompletedNCT04044547Updated Aug 5, 2019

A Study of LY03003 in Patients With Early-stage Parkinson's Disease

A Phase 1 interventional study of Rotigotine, extended-release microspheres and Placebo, extended-release microspheres in Parkinson Disease, sponsored by Luye Pharma Group Ltd.. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-08-05.

Sponsored by Luye Pharma Group Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

Registered 5 years 8 months after the study started (first participant enrolled Nov 2013, registered Jul 2019).

Phase: Phase 1
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

This study is to characterize the pharmacokinetics and to evaluate the safety as well as tolerability of LY03003 following multiple escalating intramuscular injections

Conditions studied

Parkinson Disease

Browse trials for

Parkinson Disease 4,487

Keywords

Parkinson disease
LY03003

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 60 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Luye Pharma Group Ltd. is the lead sponsor of 72 studies on the registry; 15 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 60 participants (actual)

Study arms

Experimental
LY03003
Drug: Rotigotine, extended-release microspheres
Placebo comparator
Placebo
Drug: Placebo, extended-release microspheres

Interventions

DrugRotigotine, extended-release microspheres
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.
DrugPlacebo, extended-release microspheres
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.

What researchers measure

Primary outcomes

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 outcomes

Frequency of adverse events
Adverse events to evaluate the safety and tolerability of LY03003
Time frame: From screening up to day 50
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).
Time frame: screening, baseline and day 29 and Day 50

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04044547
Lead sponsor: Luye Pharma Group Ltd.
Collaborators: Beijing Bozhiyin T&S Co., Ltd.
Responsible party: Sponsor
First posted: Aug 5, 2019
Start date: Nov 22, 2013
Primary completion: Feb 26, 2014
Completion: Jun 11, 2015
Last update: Aug 5, 2019

View the source record on ClinicalTrials.gov ↗

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