Parkinson DiseasePhase 1NCT04629404
A Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of LY03003 in Early PD Patients
A Phase 1 study testing LY03003 in people with Parkinson Disease, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
A Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of LY03003 in Early PD Patients Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- LY03003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2018to 14 Mar 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the subject or his legal representative understands and is willing to participate in this clinical study and voluntarily signs and dates the informed consent form;
- in the judgment of the investigator, the subject or his legal representative is considered trustworthy and able to comply with the study protocol, visit plan or receive the study drug as required;
- Subjects aged ≥ 30 years at screening (Visit 1), male or female;
- Meet the UK Brain Bank diagnostic criteria for essential Parkinson's disease, duration of illness ≤ 5 years, the diagnosis is based on the main sign - bradykinesia, plus at least one of the following symptoms: resting tremor, rigidity or postural reflex disorders, and no other known or suspected cause of Parkinson's disease;
- Hoehn-Yahr stage ≤ 3 (excluding stage 0) in the "on" state;
- Mini-Mental State Examination (MMSE) ≥ 25 points;
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- At baseline (Visit 2), the Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III) in the "on" state is ≥ 10;
- if the subject is receiving anticholinergic drugs (e.g., methenamine, diphenhydramine, diethylpromethazine, procyclidine, and biperiden), monoamine oxidase B (MAO-B) inhibitors (e.g., selegiline, rasagiline), N-methyl-d-aspartate (NMDA) antagonists (e.g., amantadine), the dose must be stable for at least 28 days before baseline (Visit 2), and the dose must be maintained during the study;
- Women of childbearing age (do not meet any of the following conditions: cessation of menstruation for ≥ 12 months; or underwent hysterectomy or oophorectomy; or have medically confirmed ovarian failure) or male subjects agree to take reliable contraception (oral contraceptives, use of condoms, abstinence, etc.) throughout the study (screening visit to the end of the study), and screening (Visit 1) and baseline (Visit 2), women of childbearing age pregnancy test results are negative.
Who cannot join
- history of pallidotomy, thalamic lesioning, deep brain stimulation or fetal tissue transplantation;
- suffering from dementia, active mental illness or hallucinations, major depression;
- Patients receiving dopamine agonist therapy within 28 days before baseline (Visit 2);
- received levodopa preparations (containing levodopa compound preparations) within 28 days before baseline (Visit 2);
- received any of the following drugs within 28 days before baseline (Visit 2): amphetamine, metoclopramide, α-methyldopa, anti-schizophrenia drugs, monoamine oxidase A (MAO-A) inhibitors, reserpine, methylphenidate, cloth;
- Receiving central nervous system active drug treatment (such as sedative hypnotics, antidepressants, anxiolytics), but excluding the baseline (Visit 2) has remained stable for at least 28 days, and may remain stable during the study;
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- Atypical Parkinson's disease symptoms caused by taking drugs (such as metoclopramide, flunarizine), nervous system inherited metabolic diseases (such as Wilson's disease), encephalitis, cerebrovascular disease or degenerative diseases (such as progressive supranuclear palsy);
- History of epilepsy, or stroke or transient ischemic attack within 1 year before screening (Visit 1);
- intolerant or allergic to the following antiemetics, such as domperidone, trimethobenzamide, ondansetron, tropisetron, granisetron and gronium;
- Clinically significant liver dysfunction, defined as total bilirubin > 1.5 times the upper limit of the reference range or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of the reference range;
- Clinically significant renal dysfunction (serum creatinine > 2.0 mg/dL [> 177 μmol/L]);
- uncontrolled or significant cardiovascular disease, including New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months before baseline (Visit 2), or arrhythmia requiring treatment at screening (Visit 1);
- At screening (Visit 1) and baseline (Visit 2), QTc interval: male > 470 ms, female > 480 ms;
- History of symptomatic orthostatic hypotension; or a systolic blood pressure decrease of ≥ 20 mmHg or a diastolic blood pressure decrease of ≥ 10 mmHg at 1 or 3 minutes from a recumbent to an upright position at screening (Visit 1) and baseline (Visit 2); or a supine systolic blood pressure < 105 mmHg at screening (Visit 1) and baseline (Visit 2);
- History of suicide attempt (including actual attempts, interrupted attempts, or failed attempts) or suicidal ideation in the past 6 months, defined as "yes" to question 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening (Visit 1);
- History of narcolepsy;
- History of alcoholism, drug abuse, or drug abuse within 5 years before screening (Visit 1), defined as alcohol consumption of more than 14 units of alcohol per week (1 unit = 360 ml of beer or 45 ml of spirits with an alcohol content of 40% or 150 ml of wine);
- Patients with malignant tumors within 5 years before screening (Visit 1), except for adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, local prostate cancer after radical surgery, and intraductal carcinoma in situ after radical surgery;
- Pregnant or lactating women;
- Previous participation in the rotigotine test can not tolerate or poor efficacy; Allergic constitution or known allergy to rotigotine or rotigotine microsphere preparation components;
- Allergic constitution or known allergy to rotigotine or rotigotine microsphere preparation components;
- Participated in other drug clinical trials within 3 months before screening (Visit 1);
- have other clinically significant medical conditions, psychiatric conditions or laboratory abnormalities that may interfere with the ability of the subject to participate in this study as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of Multiple Intramuscular Doses of LY03003 in Patients With Early Parkinson's Disease
A Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of LY03003 in Early PD Patients
- Conditions
- Parkinson Disease
- Being tested
- LY03003, Placebo
- Keywords
- parkinson disease, LY03003
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY03003Drug
Firstly, intramuscularly inject 14 mg of the study drug once, continue intramuscularly inject 28 mg of the study drug once after being observed for 1 week to confirm safety, continue intramuscularly inject 42 mg of the study drug once after being observed for 1 week to confirm safety, and prepare to enter the maintenance period of 56 mg dose after being observed for 1 week to confirm safety. During the dose maintenance period, 56 mg of the test drug was intramuscularly injected once a week for a total of 4 consecutive doses.
PlaceboDrug
Firstly, intramuscularly inject 14 mg of the study drug once, continue intramuscularly inject 28 mg of the study drug once after being observed for 1 week to confirm safety, continue intramuscularly inject 42 mg of the study drug once after being observed for 1 week to confirm safety, and prepare to enter the maintenance period of 56 mg dose after being observed for 1 week to confirm safety. During the dose maintenance period, 56 mg of the test drug was intramuscularly injected once a week for a total of 4 consecutive doses.
| Study group | Role | What they receive |
|---|---|---|
| LY03003 | Experimental | Not described Receives: Drug: LY03003 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic Measures
Change from baseline in (II + III) total score, Part II, Part III scores of the UPDRS
Measured: From titration to dose-maintenance at day 50
Safety Measures
Blood Pressure
Measured: From titration to dose-maintenance at day 50
Secondary outcomes (1)
Cmax,ss
Peak concentration
Measured: From titration to dose-maintenance at day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start5 Nov 2018
- Primary completion14 Mar 2019
- Study completion14 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629404
- Sponsor's protocol ID
- LY03003/CT-CHN-105
- Status last verified
- Nov 2020
- First submitted
- 5 Nov 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of Multiple Intramuscular Doses of LY03003 in Patients With Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04629404
- Acronym / sponsor ID
- LY03003/CT-CHN-105
- Conditions
- Parkinson Disease
- Keywords
- parkinson disease, LY03003
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 14 Mar 2019 (actual)
- Study completion
- 14 Mar 2019 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of LY03003 in Early PD Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY03003 | Experimental | Drug: LY03003 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- the subject or his legal representative understands and is willing to participate in this clinical study and voluntarily signs and dates the informed consent form;
- in the judgment of the investigator, the subject or his legal representative is considered trustworthy and able to comply with the study protocol, visit plan or receive the study drug as required;
- Subjects aged ≥ 30 years at screening (Visit 1), male or female;
- Meet the UK Brain Bank diagnostic criteria for essential Parkinson's disease, duration of illness ≤ 5 years, the diagnosis is based on the main sign - bradykinesia, plus at least one of the following symptoms: resting tremor, rigidity or postural reflex disorders, and no other known or suspected cause of Parkinson's disease;
- Hoehn-Yahr stage ≤ 3 (excluding stage 0) in the "on" state;
Key exclusion criteria (23 listed)
- history of pallidotomy, thalamic lesioning, deep brain stimulation or fetal tissue transplantation;
- suffering from dementia, active mental illness or hallucinations, major depression;
- Patients receiving dopamine agonist therapy within 28 days before baseline (Visit 2);
- received levodopa preparations (containing levodopa compound preparations) within 28 days before baseline (Visit 2);
- received any of the following drugs within 28 days before baseline (Visit 2): amphetamine, metoclopramide, α-methyldopa, anti-schizophrenia drugs, monoamine oxidase A (MAO-A) inhibitors, reserpine, methylphenidate, cloth;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY03003Firstly, intramuscularly inject 14 mg of the study drug once, continue intramuscularly inject 28 mg of the study drug once after being observed for 1 week to confirm safety, continue intramuscularly inject 42 mg of the study drug once after being observed for 1 week to confirm safety, and prepare to enter the maintenance period of 56 mg dose after being observed for 1 week to confirm safety. During the dose maintenance period, 56 mg of the test drug was intramuscularly injected once a week for a total of 4 consecutive doses. | Drug | LY03003 |
| PlaceboFirstly, intramuscularly inject 14 mg of the study drug once, continue intramuscularly inject 28 mg of the study drug once after being observed for 1 week to confirm safety, continue intramuscularly inject 42 mg of the study drug once after being observed for 1 week to confirm safety, and prepare to enter the maintenance period of 56 mg dose after being observed for 1 week to confirm safety. During the dose maintenance period, 56 mg of the test drug was intramuscularly injected once a week for a total of 4 consecutive doses. | Drug | Placebo |
Primary outcome
Pharmacodynamic Measures
Time frame: From titration to dose-maintenance at day 50
Change from baseline in (II + III) total score, Part II, Part III scores of the UPDRS
Safety Measures
Time frame: From titration to dose-maintenance at day 50
Blood Pressure
1 secondary outcome
Cmax,ss
Time frame: From titration to dose-maintenance at day 50
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY03003 in people with Parkinson Disease, run by Luye Pharma Group Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamic Measures (time frame: From titration to dose-maintenance at day 50). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.