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
Overview
- Phase
- Phase 3
- Intervention
- Rotigotine
- Conditions
- Parkinson's Disease
- Sponsor
- UCB Pharma
- Enrollment
- 124
- Primary Endpoint
- Change in Creatinine
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Rotigotine
Outcomes
Primary Outcomes
Change in Creatinine
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Pulse Rate (Supine, After 5 Minutes)
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Systolic Blood Pressure (Supine, After 5 Minutes)
Time Frame: Baseline, 28 Days
Change = 28 day value minus baseline value.
Change in Systolic Blood Pressure (Standing, After 1 Minute)
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Diastolic Blood Pressure (Standing, After 1 Minute)
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Pulse Rate (Standing, After 3 Minutes)
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Pulse Rate (Supine, After 1 Minute)
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Diastolic Blood Pressure (Supine, After 5 Minutes)
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in QRS Duration
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Platelet Count
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Albumin
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Calcium
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Gamma-Glutamyltransferase
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Glutamic Pyruvic Transaminase
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Systolic Blood Pressure (Supine, After 1 Minute)
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Diastolic Blood Pressure (Supine, After 1 Minute)
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Pulse Rate (Standing, After 1 Minute)
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Heart Rate
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Red Blood Cell Count
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Diastolic Blood Pressure (Standing, After 3 Minutes)
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in PR Interval
Time Frame: 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)
Time Frame: 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
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in White Blood Cell Count
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Inorganic Phosphate
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Potassium
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Systolic Blood Pressure (Standing, After 3 Minutes)
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Alkaline Phosphatase
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Chloride
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Hemoglobin
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Percentage of Lymphocytes in White Blood Cell Count
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Percentage of Monocytes in White Blood Cell Count
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Blood Urea Nitrogen
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Serum Glutamic Oxaloacetic Transaminase
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Cardiovascular'
Time Frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Musculoskeletal'
Time Frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Mental Status'
Time Frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Involuntary Movements'
Time Frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Other'
Time Frame: 28 days
Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period
Time Frame: Baseline, 56 days
Change in Percentage of Basophilic Granulocytes in White Blood Cell Count
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Glucose
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Sodium
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Psychiatric'
Time Frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Renal/Genitourological'
Time Frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Deep Tendon Reflexes'
Time Frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Muscle Strength'
Time Frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Plantar Reflex'
Time Frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Coordination/Balance'
Time Frame: 28 days
Change in Total Bilirubin
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Pulmonary'
Time Frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Other'
Time Frame: 28 days
Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs)
Time Frame: Baseline, 2 days
Change in Total Protein
Time Frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Uric Acid
Time Frame: 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'
Time Frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Dermatological'
Time Frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hepato-/Gastrointestinal'
Time Frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Metabolic/Endocrine'
Time Frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Cranial Nerve Function'
Time Frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Gait'
Time Frame: 28 days
Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment
Time Frame: Baseline, 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hematological/Lymphatic Nodes'
Time Frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Peripheral Vascular'
Time Frame: 28 days
Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs)
Time Frame: Baseline, 2 days
Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period
Time Frame: Baseline, 56 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Sensory Perception'
Time Frame: 28 days
Completion of Trial From Baseline to End of Treatment
Time Frame: Baseline, 28 days
Secondary Outcomes
- 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)