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Parkinson DiseasePhase 3NCT04571164

A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD

A Phase 3 study testing LY03003(Rotigotine,extended-release microspheres) in people with Parkinson Disease, run by Luye Pharma Group Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to evaluate the effictiveness and safety of Ly03003 following intramuscular injections 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(Rotigotine,extended-release microspheres)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
294 participants
Where
1 siteChina
Study dates
11 May 2020to 27 Sep 2022
Phase
Phase 3
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

  • Informed consent must be given to the trial 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 procedures);
  • Age ≥30 years old, regardless of gender;
  • The subject has had primary Parkinson's disease for less than 5 years, and the diagnosis is based on the main symptom -- motor delay plus at least 1 symptom: quiescence tremor, myotonia, and no other known or suspected cause of Parkinson's disease;
  • Hoehn-yahr grading ≤3 (excluding 0);
  • Brief mental state examination (MMSE) ≥25 points;
  • Unified Parkinson disease rating scale (UPDRS) motor score (part Ⅲ) 10 or higher;
  • If the subjects are receiving anticholinergic drugs (such as benzalkonium tropic, benzene hai suo, diethyl promethazine, its organism and than pp board), MAO - B inhibitors (e.g., company to gillan, LeiSha gillan), NMDA antagonists, such as amantadine treatment, must dose before baseline stability at least 28 days, and maintain the dose treatment during the study period
  • Women of childbearing age (defined as women who have not undergone surgical sterilization or less than 1 year after menopause) or male subjects agree to use reliable contraceptives (oral contraceptives, condom use, abstinence, etc.) throughout the study period (until the end of the study), and pregnancy outcomes were negative for women of childbearing age at screening and baseline.

Who cannot join

  • History of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplantation
  • Dementia, active mental illness or hallucination, major depression
  • Those who received dopamine receptor agonists within 28 days before baseline
  • Patients receiving levodopa preparation (including levodopa compound preparation) within 28 days before baseline, or levodopa preparation after diagnosis for more than 6 months
  • Patients receiving any of the following drugs within 28 days before baseline: amphetamine, metoclopramide, α-methyldopa, antipsychotics, MAO-Ainhibitors, flunarizine, reserpine, methylphenidate, budesonide, etc
  • Active central nervous system drugs (such as sedatives, hypnotics, antidepressants, and antianxiety drugs) are under treatment, except those who have maintained a stable dose for at least 28 days before the baseline (visit 2) and may remain stable during the study period
Show all 24Show fewer
  • Atypical Parkinson's disease symptoms caused by taking drugs (such as metoclopramide, flunarizine), hereditary metabolic diseases of nervous system (such as Wilson's disease), encephalitis, cerebrovascular diseases or degenerative diseases (such as progressive supranuclear paralysis)
  • Have a history of epilepsy, or have a history of stroke or transient cerebral ischemia within 1 year before the visit
  • Those who are intolerant or allergic to the following antiemetic drugs, such as domperidone, trimethoxybenzamide, ondansetron, tropisetron, granisetron and glinbromide
  • Patients with clinically significant abnormal liver function were defined as total bilirubin > 1.5 times of the upper limit of the reference value range or ALT or ast > 2 times of the upper limit of the reference value range
  • Patients with clinically significant renal dysfunction (serum creatinine > 2.0 mg / dl [> 177 μ mol / l])
  • Patients with uncontrollable or important cardiovascular diseases, including congestive heart failure of NYHA grade II or above, unstable angina pectoris, myocardial infarction within 6 months before the first administration of trial drug, or arrhythmia requiring treatment at the time of screening
  • At screening, QTc interval: male > 450ms, female > 460ms
  • Patients with a history of orthostatic hypotension, or those with SBP ≥ 20mmhg or DBP ≥ 10mmhg at screening (visit 1) and baseline (visit 2) when switching from supine position to upright position for 1 or 3 minutes; or those with SBP < 105mmhg at visit 1 and visit 2;
  • Subjects with evidence of impulse control disorder (ICD) during screening (visit 1);
  • A history of suicide attempt (including actual attempt, interruption or failure of attempt) or suicidal ideation in the past 6 months were defined as those who answered "yes" to question 4 or question 5 of the Columbia suicide severity rating scale (c-ssrs) during screening (visit 1);
  • Patients with history of narcolepsy;
  • Those who had a history of alcoholism, drug abuse and drug abuse in the past five years (visit 1) were screened. Alcoholism was defined as drinking more than 14 units of alcohol per week (1 unit = 360 ml beer or 45 ml alcohol with 40% alcohol content or 150 ml wine);
  • Patients with malignant tumor within 5 years before screening were excluded from cervical carcinoma in situ, skin basal cell or squamous cell carcinoma, local prostate cancer after radical operation and breast intraductal carcinoma in situ after radical operation;
  • Pregnant or lactating women;
  • The patients who had participated in the rotigotine test were intolerable or ineffective;
  • Allergic constitution (allergic to two or more drugs or foods) or known to be allergic to rotigotine or rotigotine microspheres;
  • Those who have participated in clinical trials of other drugs within 3 months before screening;
  • Other clinically significant medical status, mental status or laboratory abnormalities judged by the researcher may interfere with the subject's ability to participate in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xuanwu Hospital Capital Medical University

    Beijing

Other trials in China

About this study

Official title: A Multi-centre,Randomized,Double-blind,Placebo Parallel Controlled Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD

This study is to evaluate the effictiveness and safety of Ly03003 following intramuscular injections

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

    During the intervention, the initial dose was 14mg, and then was incremented in weekly units, 14mg each time, until the maximum dose of 56mg set in this study was reached 4 weeks after titration, the optimal therapeutic dose or the maximum tolerated dose was entered into the dosing maintenance period. After entering the maintenance period, no dose adjustment was performed, and the stable dose was maintained for 24 weeks

  • Placebo,extended-release microspheresDrug

    During the intervention,the initial does was 14mg,and then was incremented in weekly units,14mg each time,until the maximum does of 56mg set in this study was reached 4 weeks after titration,the optimal therapeutic does or the maximum tolerated does was entered into the dosing maintenance period.After entering the maintenance period,no does adjustment was performed,and the stable does was maintained for 24 weeks.

Study groups in NCT04571164
Study groupRoleWhat they receive
LY03003ExperimentalNot described
Receives: Drug: LY03003(Rotigotine,extended-release microspheres)
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo,extended-release microspheres

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline to the end of the treatment period in the Unified Parkinson's Disease Rating Scale(UPDRS)part(Ⅱ+Ⅲ)Total Score

    Measured: From baseline to the end of the double-blind dose maintenance period at 24weeks

Secondary outcomes (7)

  1. The proportion of patients whose total UPDRS decreased by 20、25、30percent or mors

    Measured: From baseline to the end of the double-blind dose maintenance period at 24weeks

  2. UPDRS scale part Ⅱchanges relative to the baseline

    Measured: From baseline to the end of the double-blind dose maintenance period at 24weeks

  3. UPDRS scale part Ⅲchanges relative to the baseline

    Measured: From baseline to the end of the double-blind dose maintenance period at 24weeks

  4. Changes in SI scores in the Total Clinical Efficacy Rating Scale (CGI) relative to baseline,the scores of GI and EI

    Measured: From baseline to the end of the double-blind dose maintenance period at 24weeks

  5. To clarify the changes in PDQ-8 questionnaire scores relative to baseline

    Measured: From baseline to the end of the double-blind dose maintenance period at 24weeks

  6. To clarify the changes in PDSS questionnaire scores relative to baseline

    Measured: From baseline to the end of the double-blind dose maintenance period at 24weeks

  7. To clarify the changes in BDI-Ⅱquestionnaire scores relative to baseline

    Measured: From baseline to the end of the double-blind dose maintenance period at 24weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2020
  2. Study start11 May 2020
  3. Primary completion17 Mar 2022
  4. Study completion27 Sep 2022

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
294 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04571164
Sponsor's protocol ID
LY03003/CT-CHN-304
Status last verified
May 2023
First submitted
21 Sep 2020
Last updated
6 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LY03003(Rotigotine,extended-release microspheres) 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 8 inclusion and 24 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 6 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

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: From baseline to the end of the double-blind dose maintenance period at 24weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04571164.

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 6 May 2023.

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