Parkinson's DiseasePhase 3NCT04455555
Efficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's Disease
A Phase 3 study testing LY03003( the name of rotigotine) in people with Parkinson's Disease, run by Peking University Third Hospital at 1 site in China.
Trial summary
The efficacy and safety of rotigotine in the treatment of patients with early stage of primary Parkinson's disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- LY03003( the name of rotigotine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 1 Feb 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects or their legal representatives understand and wish to participate in this clinical study and voluntarily sign the informed consent dated;
- In the investigator's judgment, believe that the subject or his legal representative is trustworthy and able to comply with the study protocol, visit plan, or receive the study drug treatment as required;
- During screening (interview 1) The subjects were older than 30 years old, regardless of gender;
- The subject had primary Parkinson's disease for 55 years and was diagnosed based on major signs such as delayed movement and at least one of the following symptoms: quiescence tremor, rigidity or postural reflexes, and no other known or suspected cause of Parkinson's disease;
- Hoehn-yahr stage 3 in the "open" state (excluding phase 0);
- Brief mental State examination (MMSE) ≥ 25;
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- At baseline (visit 2), the exercise score (Part III) of the Unified Parkinson's Disease Rating Scale (U PDRS) under the "open" condition was greater than or equal to 10;
- If the subjects are receiving anticholinergic drugs (such as benzalkonium tropic, benzene hai suo, diethyl promethazine, its organism and than pp board), monoamine oxidase B (MAO B) inhibitors, N - Methyl - d - aspartate (NMDA) antagonist (such as amantadine) treatment, must dose before baseline visit (2) is stable at least 28 days, and maintain the dose treatment during the study period;
- Childbearing age women (such as: no sterilization surgery or postmenopausal women is less than 1 year) or male subjects agreed to during the entire study (screening visit to the end of the study) and reliable contraceptive measures (birth control pills, use a condom, abstinence, etc.), and the screening visit (l) and the baseline visit (2), the childbearing age women of pregnancy test results were negative.
Who cannot join
- A history of globulin resection, thalamic destruction, deep brain stimulation or fetal tissue transplantation;
- Dementia, active mental illness or hallucinations, major depression
- Those who received dopamine agonist within 28 days before baseline (visit 2);
- Those who received levodopa preparations (including levodopa compound preparations) within 28 days before baseline (visit 2), or those who received levodopa preparations for more than 6 months after diagnosis; Patients who received any of the following drugs: amphetamine or alpha within 28 days prior to baseline (visit 2)
- Receiving Central nervous system active drug therapy (e.g., tranquilizers, sleeping pills, antidepressants, antianxiety medications), except for those who have been on a stable dose for at least 28 days prior to baseline (visit 2) and are likely to remain stable during the study period;
- Atypical Parkinson's disease symptoms caused by the use of drugs (e.g., metoclopramide, flunarizine), hereditary metabolic diseases of the nervous system (e.g., Wilson's disease), encephalitis, cerebrovascular diseases, or degenerative diseases (e.g., progressive supranuclear palsy);
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- Patients with a history of epilepsy, or with a history of stroke or transient ischemic stroke within 1 year before the visit;
- Intolerance or allergy to antiemetic drugs such as domperidone, ondansetron, tropisetron, granisetron;
- Patients with clinically significant liver function abnormalities are defined as 1.5 times of the upper limit of the reference range of total bilirubin > or 2 times of the upper limit of the reference range of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >;
- Abnormal renal function with clinical significance (serum creatinine > 2.0 mg/dL);
- Uncontrolled or significant cardiovascular disease, including New York Heart Association grade 2 or above congestive heart failure, unstable angina, myocardial infarction, or arrhythmias requiring treatment at screening (visit 1) in the 6 months prior to first administration of the study drug;
- During screening (interview I);
- A history of symptomatic postural hypotension; Systolic blood pressure reduction greater than or equal to 20 MMHG or diastolic blood pressure reduction greater than or equal to 10 mmHg during screening (visit l) and baseline (visit 2) from baseline to upright position for 1 or 3 minutes; Or patients with horizontal systolic blood pressure < 105 mmHg during screening (visit I) and baseline (visit 2);
- Subjects with evidence of impulse control disorder (ICD) during screening (interview L);
- A history of suicide attempt (including actual attempt, interruption of attempt or failure of attempt) or suicidal ideation in the past 6 months, defined as "yes" to question 4 or 5 on the Columbine Suicide Severity Rating Scale (C-SSRS) at screening (interview L); those
- Patients with a history of narcolepsy;
- Screening (interview L) For those who had a history of alcohol abuse, drug abuse or drug addiction in the first 5 years, alcoholism was defined as drinking more than 14 units of alcohol per week (1 unit = 360 ml beer or 45 ml spirits with 40% alcohol or 150 ml wine);
- Screening for malignant tumors within 5 years before surgery, except adequately treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, local prostate cancer after radical surgery, and intraductal carcinoma in situ of the breast;
- Women during pregnancy or lactation;
- Previous participants in the Rotigotine trial were intolerant or had poor efficacy;
- Allergic to or known to be allergic to rotigotine or rotigotine microsphere preparations;
- Those who have participated in other drug clinical trials within 3 months prior to screening;
- Any other medical condition, mental condition, or laboratory abnormality of clinical significance that the investigator determines may interfere with the subject's ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The efficacy and safety of rotigotine in the treatment of patients with early stage of primary Parkinson's disease
Read the detailed description
To evaluate the efficacy and safety of rotigotine sustained release microspheres therapy by injection in the treatment of patients with early stage of primary Parkinson's disease
- Conditions
- Parkinson's Disease
- Being tested
- LY03003( the name of rotigotine), Placebo
- Keywords
- Parkinson's disease；rotigotine
- 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( the name of rotigotine)Drug
LY03003 (Continuous Dopamine Stimulation) sustained release microspheres / injection once a week 4 weeks followed by 24 weeks until 28 weeks.
PlaceboOther
Null sustained release microspheres placebo / injection once a week 4 weeks followed by 24 weeks until 28 weeks.
| Study group | Role | What they receive |
|---|---|---|
| rotigotine treatment group | Experimental | rotigotine sustained release microspheres therapy by injection Receives: Drug: LY03003( the name of rotigotine) |
| placebo comparator | Placebo comparator | placebo comparator/null microspheres Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the total Unified Parkinson Disease Rating Scale (UPDRS) (II +III) score
Changes in the total Unified Parkinson Disease Rating Scale (UPDRS) (II +III) score relative to baseline from baseline to the end of the double-blind dose maintenance period, The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Some sections of the UPDRS scale require multiple grades assigned to each extremity with a possible maximum of 199 points. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability).
Measured: 32 weeks after treatment
Secondary outcomes (6)
Unified Parkinson Disease Rating Scale (UPDRS) maximum table (II +III) total score
Unified Parkinson Disease Rating Scale (UPDRS) maximum table (II +III) total score relative to baseline from baseline to the end of the double-blind dose maintenance period, The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Some sections of the UPDRS scale require multiple grades assigned to each extremity with a possible maximum of 199 points. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability).
Measured: 32 weeks after treatment
changes in part II of the Unified Parkinson Disease Rating Scale relative to baseline
Changes from baseline to the end of the double-blind dose maintenance period in part III of the Unified Parkinson Disease Rating Scale relative to baseline; The Unified Parkinson Disease Rating Scale scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Some sections of the Unified Parkinson Disease Rating Scale scale require multiple grades assigned to each extremity with a possible maximum of 199 points. A score of 199 on the Unified Parkinson Disease Rating scale represents the worst (total disability) with a score of zero representing (no disability).
Measured: 32 weeks after treatment
changes in the severity (SI) score;
From baseline to the end of the double-blind dose maintenance period, changes in the severity (SI) score of Item 1 ;The Severity Score (ISS) scores ranges from 0 to 75 (i.e. Abbreviated Scale (AIS) scores of 6 for each injury in every body region according to its relative severity). If an injury is assigned an Abbreviated Injury Scale (AIS) of 6 (identified currently as untreatable injury or unsurvivable injury), the ISS score is automatically assigned 75. Since a score of 6 ("unsurvivable") indicates the futility of further medical care in preserving life, this may mean a cessation of further care in triage for a patient with a score of 6 in any category.
Measured: 32 weeks after treatment
Changes in pd Questionnaire (PDQ-8) scores
Changes in pd Questionnaire (PDQ-8) scores relative to baseline from baseline to the end of the double-blind dose maintenance period; the higher the score, the worse of life quality
Measured: 32 weeks after treatment
Changes in pd sleep Disorders Scale (PDSS) score
Changes in pd sleep Disorders Scale (PDSS) score from baseline to the end of the double-blind dose maintenance period. The overall PDSS is the summary score of the single PDSS items. If the single items have values between 0 (= worst case) to 10 (= best case) the total score can range between 0 and 150. Score 150 means the best case.
Measured: 32 weeks after treatment
Changes in Beck Depression Inventory II (BDI-II) scores
Changes in Beck Depression Inventory II (BDI-II) scores relative to baseline from baseline to the end of the double-blind dose maintenance period. Each item of the BDI-II is rated along a 4-point Likert scale from 0 to 3； Items are summed to produce a total score（0-63） with higher scores representing more depressive symptoms.
Measured: 32 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Aug 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dongsheng Fan, MD.PHD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455555
- Sponsor's protocol ID
- PUTH2018083
- Status last verified
- Jul 2020
- First submitted
- 28 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04455555
- Acronym / sponsor ID
- PUTH2018083
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease；rotigotine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 2 Jul 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.
The efficacy and safety of rotigotine in the treatment of patients with early stage of primary Parkinson's disease
Detailed description
To evaluate the efficacy and safety of rotigotine sustained release microspheres therapy by injection in the treatment of patients with early stage of primary Parkinson's disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rotigotine treatment group | Experimental | Drug: LY03003( the name of rotigotine)rotigotine sustained release microspheres therapy by injection |
| placebo comparator | Placebo comparator | Other: Placeboplacebo comparator/null microspheres |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects or their legal representatives understand and wish to participate in this clinical study and voluntarily sign the informed consent dated;
- In the investigator's judgment, believe that the subject or his legal representative is trustworthy and able to comply with the study protocol, visit plan, or receive the study drug treatment as required;
- During screening (interview 1) The subjects were older than 30 years old, regardless of gender;
- The subject had primary Parkinson's disease for 55 years and was diagnosed based on major signs such as delayed movement and at least one of the following symptoms: quiescence tremor, rigidity or postural reflexes, and no other known or suspected cause of Parkinson's disease;
- Hoehn-yahr stage 3 in the "open" state (excluding phase 0);
Key exclusion criteria (23 listed)
- A history of globulin resection, thalamic destruction, deep brain stimulation or fetal tissue transplantation;
- Dementia, active mental illness or hallucinations, major depression
- Those who received dopamine agonist within 28 days before baseline (visit 2);
- Those who received levodopa preparations (including levodopa compound preparations) within 28 days before baseline (visit 2), or those who received levodopa preparations for more than 6 months after diagnosis; Patients who received any of the following drugs: amphetamine or alpha within 28 days prior to baseline (visit 2)
- Receiving Central nervous system active drug therapy (e.g., tranquilizers, sleeping pills, antidepressants, antianxiety medications), except for those who have been on a stable dose for at least 28 days prior to baseline (visit 2) and are likely to remain stable during the study period;
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( the name of rotigotine)LY03003 (Continuous Dopamine Stimulation) sustained release microspheres / injection once a week 4 weeks followed by 24 weeks until 28 weeks. | Drug | rotigotine treatment group |
| PlaceboNull sustained release microspheres placebo / injection once a week 4 weeks followed by 24 weeks until 28 weeks. | Other | placebo comparator |
Primary outcome
Changes in the total Unified Parkinson Disease Rating Scale (UPDRS) (II +III) score
Time frame: 32 weeks after treatment
Changes in the total Unified Parkinson Disease Rating Scale (UPDRS) (II +III) score relative to baseline from baseline to the end of the double-blind dose maintenance period, The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Some sections of the UPDRS scale require multiple grades assigned to each extremity with a possible maximum of 199 points. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability).
6 secondary outcomes
Unified Parkinson Disease Rating Scale (UPDRS) maximum table (II +III) total score
Time frame: 32 weeks after treatment
changes in part II of the Unified Parkinson Disease Rating Scale relative to baseline
Time frame: 32 weeks after treatment
changes in the severity (SI) score;
Time frame: 32 weeks after treatment
Changes in pd Questionnaire (PDQ-8) scores
Time frame: 32 weeks after treatment
Changes in pd sleep Disorders Scale (PDSS) score
Time frame: 32 weeks after treatment
Changes in Beck Depression Inventory II (BDI-II) scores
Time frame: 32 weeks after treatment
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 2 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Dongsheng Fan, MD.PHD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LY03003( the name of rotigotine) in people with Parkinson's Disease, run by Peking University Third Hospital 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 2 Jul 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 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?
Changes in the total Unified Parkinson Disease Rating Scale (UPDRS) (II +III) score (time frame: 32 weeks after treatment). 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 2 Jul 2020.