Efficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's Disease

NCT04455555 | Completed Phase 3

• 1 other identifier: PUTH2018083
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

The efficacy and safety of rotigotine in the treatment of patients with early stage of primary Parkinson's disease

Conditions

Parkinson's Disease

Keywords

Parkinson's disease；rotigotine

Outcome Measures

Primary Outcomes (1)

• 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).

  32 weeks after treatment

Secondary Outcomes (6)

• Unified Parkinson Disease Rating Scale (UPDRS) maximum table (II +III) total score

  32 weeks after treatment

• changes in part II of the Unified Parkinson Disease Rating Scale relative to baseline

  32 weeks after treatment

• changes in the severity (SI) score;

  32 weeks after treatment

• Changes in pd Questionnaire (PDQ-8) scores

  32 weeks after treatment

• Changes in pd sleep Disorders Scale (PDSS) score

  32 weeks after treatment

Study Arms (2)

rotigotine treatment group

EXPERIMENTAL

rotigotine sustained release microspheres therapy by injection

Drug: LY03003( the name of rotigotine)

placebo comparator

PLACEBO COMPARATOR

placebo comparator/null microspheres

Other: Placebo

Interventions

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.

rotigotine treatment group

Placebo OTHER

Null sustained release microspheres placebo / injection once a week 4 weeks followed by 24 weeks until 28 weeks.

placebo comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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);
• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Dongsheng Fan, MD.PHD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: participant and investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 2, 2020
• Study Start: August 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: July 2, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)