Parkinson DiseasePhase 1NCT04630860
A Study to Evaluate the Pharmacokinetics and Safety of LY03003 in Patients With Advanced-stage PD
A Phase 1 study testing LY03003 in people with Parkinson Disease, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
This study is to evaluate the pharmacokinetics and safety of LY03003 in patients with advanced-stage PD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- LY03003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2020to 25 Jan 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent must be given to the study 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 test procedures);
- During screening, subjects are 18-80 years old (including boundary value), regardless of gender;
- Male subjects shall weigh no less than 50kg and female subjects shall weigh no less than 45kg. Body mass index within the range of 19~30kg/m2 (including critical value);
- Meet the diagnostic criteria of MDS for primary Parkinson's disease with sick time more than 3 years. The diagnosis is based on the main symptoms-motor retardation, plus at least one of the following symptoms: quiescence tremor, myotonia, and no other known or suspected causes of Parkinson's disease;
- In the "on" state, subjects' HOehn-YahR rating is from level 2 to level 3;
- A concise Mental State Scale (MMSE) score ≥25;
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- A steady dose of Levodopa (either monotherapy or in combination with benserazide/carbidopa/carbidopa) shall be administered at least 2 times a day for a minimum of 28 days prior to baseline;
- if you are accept anticholinergic drugs (such as benzalkonium tropic, benzene hai suo, diethyl promethazine, its organism and than pp board), monoamine oxidase B (MAO B) inhibitors (e.g., company to gillan, LeiSha gillan) and/or N - methyl - d - aspartate (NMDA) antagonist (such as amantadine) treatment, must be accepted before baseline at least 28 days, stable doses and during the study period to maintain the therapeutic dose;
- Women of childbearing age (those who do not meet any of the following conditions: menstrual stop ≥ 12 months; Or had undergone hysterectomy or bilateral oophorectomy; (or with medically confirmed ovarian failure) or male subjects agree to use reliable contraceptives (oral contraceptives, condom use, abstinence, etc.) throughout the study period (screening visits until the end of the study), and pregnancy tests for women of childbearing age are negative at screening and baseline.
Who cannot join
- Patients with atypical Parkinson's disease caused by the use of drugs (such as methoxylopramine, flunarizine), hereditary metabolic diseases of the nervous system (such as Wilson's disease), encephalitis, cerebrovascular diseases or degenerative diseases (such as progressive supravuclear palsy);
- The author had a history of epilepsy, or had a history of stroke or transient ischemic stroke within 1 year before the visit;
- Dementia, active mental illness or hallucinations, major depression;
- Those with a history of suicide attempts (including actual attempts, attempts interrupted or failed) or suicidal ideation in the past 6 months, defined as those who answered "yes" to question 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the time of screening;
- Patients with a history of narcolepsy;
- There is impulse control disorder (ICD) evidence;
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- Uncontrolled or severe cardiovascular disease, including New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina, myocardial infarction, or the presence of arrhythmia requiring treatment during screening;
- Patients with malignant tumors within 5 years before screening, except for 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;
- History of pallidotomy, thalamic lesion, deep brain stimulation or fetal tissue transplantation;
- received cabergoline or bromocriptine within 15 days before baseline, or received other dopamine agonists within 7 days before baseline;
- Patients received any of the following drugs within 28 days before baseline: α-methyldopa, metoclopramide, flunarizine, reserpine, antipsychotics, monoamine oxidase A (MAO-A) inhibitors, methylphenidate, amphetamine, cloth, etc.;
- Currently receiving treatment for central nervous system diseases (e.g., sedatives, hypnotics, antidepressants, anxiolytics), unless the dose is stable for at least 28 days before baseline, and the treatment dose is maintained during the study period;
- Known history of intolerance/allergy to the following antiemetics: domperidone, trimethoxybenzamide, ondansetron, tropisetron, granisetron, and glycopyrrolate;
- Screening or baseline, ECG examination QTc > 450 milliseconds (male) or > 460 milliseconds (female) or other abnormalities judged by the investigator have clinical significance;
- History of orthostatic hypotension; or systolic blood pressure (SBP) decreased by ≥ 20 mmHg or diastolic blood pressure (DBP) decreased by ≥ 10 mmHg when changing from the decubitus position to the upright position for 1 or 3 minutes at screening or baseline; or systolic pressure < 105 mmHg at screening or baseline;
- Clinically significant abnormal liver function, 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 or > 177 umol/L]);
- Any test result of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody is positive;
- Smokers, alcoholics:
- Smoking is defined as: an average daily smoking of ≥ 5 cigarettes within 3 months before screening; B) Alcohol abuse is defined as: drinking more than 14 units of alcohol per week (1 unit = 350 mL of beer, or 45 mL of liquor, or 150 mL of wine) within 3 months before screening.
- Pregnant or lactating women;
- Allergic constitution (allergic to two or more drugs or food) or known to be allergic to rotigotine or rotigotine microsphere preparation ingredients;
- Previous use of rotigotine-containing preparations can not tolerate or poor efficacy;
- Participated in other drug clinical trials within 3 months before screening;
- Other clinically significant medical conditions, mental 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, Open-label, Multiple Ascending Dose Study in Patients With Advanced-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections
This study is to evaluate the pharmacokinetics and safety of LY03003 in patients with advanced-stage PD.
- Conditions
- Parkinson Disease
- Being tested
- LY03003
- 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
Rotigotine,extended-release microspheres
| Study group | Role | What they receive |
|---|---|---|
| 56mg dose group | Experimental | Not described Receives: Drug: LY03003 |
| 84mg dose group | Experimental | Not described Receives: Drug: LY03003 |
| 112mg dose group | Experimental | Not described Receives: Drug: LY03003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation
Blood pressure
Measured: From Titration Period to Day 50 of Dose Maintenance Period
Cmax ,ss
Peak concentration
Measured: From Titration Period to Day 50 of Dose Maintenance Period
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 start7 Jul 2020
- Primary completion12 May 2021
- Study completion25 Jan 2022
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT04630860
- Sponsor's protocol ID
- LY03003/CT-CHN-106
- Status last verified
- May 2023
- First submitted
- 5 Nov 2020
- Last updated
- 16 May 2023
- 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 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple Ascending Dose Study in Patients With Advanced-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections
- ClinicalTrials.gov ID
- NCT04630860
- Acronym / sponsor ID
- LY03003/CT-CHN-106
- Conditions
- Parkinson Disease
- Keywords
- parkinson disease, LY03003
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 25 Jan 2022 (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.
This study is to evaluate the pharmacokinetics and safety of LY03003 in patients with advanced-stage PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 56mg dose group | Experimental | Drug: LY03003 |
| 84mg dose group | Experimental | Drug: LY03003 |
| 112mg dose group | Experimental | Drug: LY03003 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed consent must be given to the study 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 test procedures);
- During screening, subjects are 18-80 years old (including boundary value), regardless of gender;
- Male subjects shall weigh no less than 50kg and female subjects shall weigh no less than 45kg. Body mass index within the range of 19~30kg/m2 (including critical value);
- Meet the diagnostic criteria of MDS for primary Parkinson's disease with sick time more than 3 years. The diagnosis is based on the main symptoms-motor retardation, plus at least one of the following symptoms: quiescence tremor, myotonia, and no other known or suspected causes of Parkinson's disease;
- In the "on" state, subjects' HOehn-YahR rating is from level 2 to level 3;
Key exclusion criteria (25 listed)
- Patients with atypical Parkinson's disease caused by the use of drugs (such as methoxylopramine, flunarizine), hereditary metabolic diseases of the nervous system (such as Wilson's disease), encephalitis, cerebrovascular diseases or degenerative diseases (such as progressive supravuclear palsy);
- The author had a history of epilepsy, or had a history of stroke or transient ischemic stroke within 1 year before the visit;
- Dementia, active mental illness or hallucinations, major depression;
- Those with a history of suicide attempts (including actual attempts, attempts interrupted or failed) or suicidal ideation in the past 6 months, defined as those who answered "yes" to question 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the time of screening;
- Patients with a history of narcolepsy;
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 |
|---|---|---|
| LY03003Rotigotine,extended-release microspheres | Drug | 112mg dose group, 56mg dose group, 84mg dose group |
Primary outcome
Safety evaluation
Time frame: From Titration Period to Day 50 of Dose Maintenance Period
Blood pressure
Cmax ,ss
Time frame: From Titration Period to Day 50 of Dose Maintenance Period
Peak concentration
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 May 2023.
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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 25 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 May 2023. 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. 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?
Safety evaluation (time frame: From Titration Period to Day 50 of Dose Maintenance Period). 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 May 2023.