A Phase 3b, Open-Label, Multicenter Trial to Assess the Safety and Tolerability of Switching Korean Subjects From Ropinirole to the Rotigotine Transdermal System and Its Effect on Symptoms in Idiopathic Parkinson's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 124
- 主要终点
- Change in Creatinine
研究概览
简要总结
This is a Phase 3b, open-label, multicenter trial to assess the safety and tolerability of switching from ropinirole therapy to the rotigotine transdermal system and its effect on symptoms in subjects with idiopathic Parkinson's disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is informed and given ample time and opportunity to think about his/her participation in this trial and has given his/her written informed consent.
- •Subject is willing and able to comply with all trial requirements.
- •Subject is male or female, aged≥ 18 years.
- •Subject is Korean.
- •Subjects with idiopathic Parkinson's disease (Hoehn and Yahr Stage I-IV) as defined by the cardinal sign, bradykinesia, and at least 1 of the following: resting tremor, rigidity, or impairment of postural reflexes.
- •Subject is not satisfactorily controlled on a total daily dose of ropinirole from 3mg to 12mg, inclusive.
- •If the subject is receiving levodopa, either short-acting or sustained-release (in combination with benserazide or carbidopa), the total daily dose must be stable for 28 days prior to the Baseline Visit and must remain stable for the Treatment Period.
- •If the subject is receiving an anticholinergic agent (eg, benztropine, trihexyphenidyl, parsitan, procyclidine, biperiden), a monoamine oxidase B (MAO-B) inhibitor (eg, selegiline), a COMT inhibitor (eg, entacapone), or an N-methyl-d-aspartate (NMDA)-antagonist (eg, amantadine), he/she must have been on a stable dose for at least 28 days prior to the Baseline Visit and must be maintained on that dose for the Treatment Period
排除标准
- •Subjects are not permitted to enroll in the trial if any of the following criteria are met:
- •Subject has previously participated in a trial with rotigotine.
- •Subject has participated in another trial of an investigational drug within 28 days prior to the Baseline Visit or is currently participating in another trial of an investigational drug.
- •Subject has atypical Parkinsonian syndrome(s), including drug-induced Parkinsonian syndrome(s).
- •Subject has dementia, active psychosis, or hallucinations (not due to antiparkinsonian medication).
- •Subject is receiving therapy with 1 of the following drugs either concurrently or within 28 days prior to Baseline Visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, quetiapine), monoamine oxidase A (MAO-A) inhibitors, methylphenidate, or amphetamine.
- •Subject is currently receiving central nervous system (CNS) active therapy (eg, sedatives, hypnotics, antidepressants, anxiolytics), unless the dose has been stable for at least 28 days prior to the Baseline Visit and is likely to remain stable for the duration of the trial.
- •Subject has a history of seizures or stroke within 1 year, has had a Transient Ischemic Attack (TIA) within 12 months prior to enrollment, or a history of myocardial infarction within the last 6 months prior to enrollment.
- •Presence of clinically relevant hepatic dysfunction.
- •Presence of clinically relevant renal dysfunction.
- •Evidence of clinically relevant cardiovascular disorders.
- •Subject has a QTcB interval of ≥ 500ms at Pretreatment or Baseline (repeated measurements within 1 hour).
- •Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in the 6 months prior to Baseline.
- •Subject has a history of significant skin hypersensitivity to adhesive or other transdermals or recent unresolved contact dermatitis.
- •Subject has malignant neoplastic disease requiring therapy within 12 months prior to enrollment.
- •Subject has a history of chronic alcohol or drug abuse within the last 6 months.
- •Subject has taken herbal medicine therapy within the last 2 weeks prior to the Baseline Visit.
- •Subject has clinically significant laboratory results that, in the judgment of the investigator, would make the subject unsuitable for entry into the trial.
- •Subject is pregnant or nursing, or is of childbearing potential but (i) not surgically sterile or (ii) not using adequate birth control methods (including at least 1 barrier method), or (iii) not sexually abstinent or (iv) not at least 2 years postmenopausal.
- •Subject has evidence of an impulse control disorder according to the Jay Modified Minnesota Impulsive Disorders Interview (mMIDI) at Pretreatment (Visit 1).
- •Subject has any other clinically significant medical or psychiatric condition that would, in the judgment of the investigator, interfere with the subject's ability to participate in this trial.
研究组 & 干预措施
Rotigotine
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
干预措施: Rotigotine (Drug)
结局指标
主要结局
Change in Creatinine
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Pulse Rate (Supine, After 5 Minutes)
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Systolic Blood Pressure (Supine, After 5 Minutes)
时间窗: Baseline, 28 Days
Change = 28 day value minus baseline value.
Change in Systolic Blood Pressure (Standing, After 1 Minute)
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Diastolic Blood Pressure (Standing, After 1 Minute)
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Pulse Rate (Standing, After 3 Minutes)
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Pulse Rate (Supine, After 1 Minute)
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Diastolic Blood Pressure (Supine, After 5 Minutes)
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in QRS Duration
时间窗: Baseline, 28 days
The QRS duration represents the time it takes for ventricular depolarization to occur. Change = 28 day value minus baseline value.
Change in QT Interval
时间窗: Baseline, 28 days
The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization. Change = 28 day value minus baseline value.
Change in Hematocrit
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Platelet Count
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Albumin
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Calcium
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Gamma-Glutamyltransferase
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Glutamic Pyruvic Transaminase
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Systolic Blood Pressure (Supine, After 1 Minute)
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Diastolic Blood Pressure (Supine, After 1 Minute)
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Pulse Rate (Standing, After 1 Minute)
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Heart Rate
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Red Blood Cell Count
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Diastolic Blood Pressure (Standing, After 3 Minutes)
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in PR Interval
时间窗: Baseline, 28 days
The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization (beginning of the QRS complex). Change = 28 day value minus baseline value.
Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB)
时间窗: Baseline, 28 days
The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization. Change = 28 day value minus baseline value.
Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in White Blood Cell Count
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Inorganic Phosphate
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Potassium
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Systolic Blood Pressure (Standing, After 3 Minutes)
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Alkaline Phosphatase
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Chloride
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Hemoglobin
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Percentage of Lymphocytes in White Blood Cell Count
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Percentage of Monocytes in White Blood Cell Count
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Blood Urea Nitrogen
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Serum Glutamic Oxaloacetic Transaminase
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Cardiovascular'
时间窗: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Musculoskeletal'
时间窗: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Mental Status'
时间窗: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Involuntary Movements'
时间窗: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Other'
时间窗: 28 days
Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period
时间窗: Baseline, 56 days
Change in Percentage of Basophilic Granulocytes in White Blood Cell Count
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Glucose
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Sodium
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Psychiatric'
时间窗: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Renal/Genitourological'
时间窗: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Deep Tendon Reflexes'
时间窗: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Muscle Strength'
时间窗: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Plantar Reflex'
时间窗: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Coordination/Balance'
时间窗: 28 days
Change in Total Bilirubin
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Pulmonary'
时间窗: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Other'
时间窗: 28 days
Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs)
时间窗: Baseline, 2 days
Change in Total Protein
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Uric Acid
时间窗: Baseline, 28 days
Change = 28 day value minus baseline value.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Ears, Eyes, Nose, Mouth, Throat'
时间窗: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Dermatological'
时间窗: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hepato-/Gastrointestinal'
时间窗: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Metabolic/Endocrine'
时间窗: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Cranial Nerve Function'
时间窗: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Gait'
时间窗: 28 days
Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment
时间窗: Baseline, 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hematological/Lymphatic Nodes'
时间窗: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Peripheral Vascular'
时间窗: 28 days
Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs)
时间窗: Baseline, 2 days
Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period
时间窗: Baseline, 56 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Sensory Perception'
时间窗: 28 days
Completion of Trial From Baseline to End of Treatment
时间窗: Baseline, 28 days
次要结局
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment(Baseline, 28 days)
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment(Baseline, 28 days)
- Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment(Baseline, 28 days)
- Clinical Global Impression (CGI) Item 3.1(28 days)
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment(Baseline, 28 days)
- Patient Global Impression (PGI) Item 1 Score(28 days)
- Patient Treatment Preference Scale Question 3(28 days)
- Patient Treatment Preference Scale Question 7(28 days)
- Change in Parkinson's Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment(Baseline, 28 days)
- Patient Global Impression (PGI) Item 2(28 days)
- Patient Treatment Preference Scale Question 4(28 days)
- Patient Treatment Preference Scale Question 6(28 days)
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment(Baseline, 28 days)
- Change in Parkinson's Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment(Baseline, 28 days)
- Clinical Global Impression (CGI) Item 2 Score(28 days)
- Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment(Baseline, 28 days)
- Patient Treatment Preference Scale Question 2(28 days)
- Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment(Baseline, 28 days)
- Patient Global Impression (PGI) Item 3(28 days)
- Clinical Global Impression (CGI) Item 3.2(28 days)
- Patient Treatment Preference Scale Question 1(28 days)
- Patient Treatment Preference Scale Question 5(28 days)