Parkinson DiseasePhase 1NCT04045678
A Multiple Ascending Dose Study With LY03003 in Patients With Early-stage Parkinson's Disease
A Phase 1 study testing LY03003 ( Rotigotine, extended-release microspheres) in people with Parkinson Disease, run by Luye Pharma Group Ltd. at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- LY03003 ( Rotigotine, extended-release microspheres)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesChina
- Study dates
- 10 Oct 2017to 21 Jun 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Chinese PLA General Hospital
Beijing
Xuanwu Hospital Capital Medical University
Beijing
Shengjing Hospital of China Medical University
Shenyang
About this study
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
This study is to evaluate the safety and tolerability and to characterize the pharmacokinetics of multiple ascending dose (MAD) of LY03003 following intramuscular injections.
- Conditions
- Parkinson Disease
- Being tested
- LY03003 ( Rotigotine, extended-release microspheres), Placebo, extended-release microspheres
- 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.
LY03003 ( Rotigotine, extended-release microspheres)Drug
Patients to be enrolled to 70 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week and then 70 mg in the next 5 weeks.
Patients to be enrolled to 84 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week, 70mg in the fifth week and then 84 mg in the next 5 weeks.
Placebo, extended-release microspheresDrug
Patients to be enrolled to 70 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week and then 70 mg in the next 5 weeks.
Patients to be enrolled to 84 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week, 70mg in the fifth week and then 84 mg in the next 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| LY03003 | Experimental | Not described Receives: Drug: LY03003 ( Rotigotine, extended-release microspheres) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo, extended-release microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events
Adverse events to evaluate the safety and tolerability of LY03003
Measured: From screening up to day 50
Secondary outcomes (13)
Time of maximum concentration (Tmax) of total LY03003
Measured: From the first injection of stable doses up to day 50
Maximum concentration in plasma (Cmax) of total LY03003
Measured: From the first injection of stable doses up to day 50
Area under the concentration-time curve (AUC) from zero up to the last measured concentration [AUC (0-t)] of LY03003
Measured: From the first injection of stable doses up to day 50
Area under the concentration-time curve (AUC) from time zero up to the infinite time [AUC (0-∞)] of LY03003
Measured: From the first injection of stable doses up to day 50
Apparent volume of distribution (Vd) of LY03003
Measured: From the first injection of stable doses up to day 50
Terminal half-life (t1/2) of total LY03003
Measured: From the first injection of stable doses up to day 50
Total body clearance of LY03003
Measured: From the first injection of stable doses up to day 50
Maximum steady-state drug concentration of LY03003
Measured: From the first injection of stable doses up to day 50
Minimum steady-state drug concentration of LY03003
Measured: From the first injection of stable doses up to day 50
Average steady-state concentration of LY03003
Measured: From the first injection of stable doses up to day 50
Area under the concentration-time curve (AUC) at steady-state concentration of LY03003
Measured: From the first injection of stable doses up to day 50
Fluctuation degree in steady-state concentration of LY03003
Measured: From the first injection of stable doses up to day 50
Change from baseline to the end of the treatment period in the Unified Parkinson's Disease Rating Scale (UPDRS) part (Ⅱ+Ⅲ) Total Score
The Unified Parkinson´s Disease Rating Scale Part Ⅱ measures "Activities in Daily Living". The total score ranges from 0 (Best score possible) to 52 (Worst score possible).
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 to 108.
Measured: Screening, baseline, days 29 and day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start10 Oct 2017
- Primary completion16 Apr 2019
- Study completion21 Jun 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Bozhiyin T&S Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045678
- Sponsor's protocol ID
- LY03003/CT-CHN-103
- Status last verified
- Sep 2020
- First submitted
- 30 Jul 2019
- Last updated
- 22 Sep 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 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04045678
- Acronym / sponsor ID
- LY03003/CT-CHN-103
- 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)
- Collaborators
- Beijing Bozhiyin T&S Co., Ltd.
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 5 Aug 2019 (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 safety and tolerability and to characterize the pharmacokinetics of multiple ascending dose (MAD) of LY03003 following intramuscular injections.
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 ( Rotigotine, extended-release microspheres) |
| Placebo | Placebo comparator | Drug: Placebo, extended-release microspheres |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
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 |
|---|---|---|
| LY03003 ( Rotigotine, extended-release microspheres)Patients to be enrolled to 70 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week and then 70 mg in the next 5 weeks. Patients to be enrolled to 84 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week, 70mg in the fifth week and then 84 mg in the next 5 weeks. | Drug | LY03003 |
| Placebo, extended-release microspheresPatients to be enrolled to 70 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week and then 70 mg in the next 5 weeks. Patients to be enrolled to 84 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week, 70mg in the fifth week and then 84 mg in the next 5 weeks. | Drug | Placebo |
Primary outcome
Frequency of adverse events
Time frame: From screening up to day 50
Adverse events to evaluate the safety and tolerability of LY03003
13 secondary outcomes
Time of maximum concentration (Tmax) of total LY03003
Time frame: From the first injection of stable doses up to day 50
Maximum concentration in plasma (Cmax) of total LY03003
Time frame: From the first injection of stable doses up to day 50
Area under the concentration-time curve (AUC) from zero up to the last measured concentration [AUC (0-t)] of LY03003
Time frame: From the first injection of stable doses up to day 50
Area under the concentration-time curve (AUC) from time zero up to the infinite time [AUC (0-∞)] of LY03003
Time frame: From the first injection of stable doses up to day 50
Apparent volume of distribution (Vd) of LY03003
Time frame: From the first injection of stable doses up to day 50
Terminal half-life (t1/2) of total LY03003
Time frame: From the first injection of stable doses up to day 50
Total body clearance of LY03003
Time frame: From the first injection of stable doses up to day 50
Maximum steady-state drug concentration of LY03003
Time frame: From the first injection of stable doses up to day 50
Minimum steady-state drug concentration of LY03003
Time frame: From the first injection of stable doses up to day 50
Average steady-state concentration of LY03003
Time frame: From the first injection of stable doses up to day 50
Area under the concentration-time curve (AUC) at steady-state concentration of LY03003
Time frame: From the first injection of stable doses up to day 50
Fluctuation degree in steady-state concentration of LY03003
Time frame: From the first injection of stable doses up to day 50
Change from baseline to the end of the treatment period in the Unified Parkinson's Disease Rating Scale (UPDRS) part (Ⅱ+Ⅲ) Total Score
Time frame: Screening, baseline, days 29 and 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 22 Sep 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.
3 sites 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 ( Rotigotine, extended-release microspheres) in people with Parkinson Disease, run by Luye Pharma Group Ltd. at 3 sites 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 6 inclusion and 17 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 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Frequency of adverse events (time frame: From screening up to day 50). 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 22 Sep 2020.