- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00593606
Safety and Tolerability Trial of Switching From Ropinirole to Rotigotine
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
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
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Strength: 2,4,6,and 8mg/24h, form: transdermal application, once daily application
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in Pulse Rate (Supine, After 1 Minute)
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Systolic Blood Pressure (Supine, After 1 Minute)
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Diastolic Blood Pressure (Supine, After 1 Minute)
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Pulse Rate (Supine, After 5 Minutes)
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Systolic Blood Pressure (Supine, After 5 Minutes)
Lasso di tempo: Baseline, 28 Days
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Change = 28 day value minus baseline value.
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Baseline, 28 Days
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Change in Diastolic Blood Pressure (Supine, After 5 Minutes)
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Pulse Rate (Standing, After 1 Minute)
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Systolic Blood Pressure (Standing, After 1 Minute)
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Diastolic Blood Pressure (Standing, After 1 Minute)
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Pulse Rate (Standing, After 3 Minutes)
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Systolic Blood Pressure (Standing, After 3 Minutes)
Lasso di tempo: Baseline, 28 days
|
Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Diastolic Blood Pressure (Standing, After 3 Minutes)
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Heart Rate
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in PR Interval
Lasso di tempo: Baseline, 28 days
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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. |
Baseline, 28 days
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Change in QRS Duration
Lasso di tempo: Baseline, 28 days
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The QRS duration represents the time it takes for ventricular depolarization to occur. Change = 28 day value minus baseline value. |
Baseline, 28 days
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Change in QT Interval
Lasso di tempo: Baseline, 28 days
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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. |
Baseline, 28 days
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Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB)
Lasso di tempo: Baseline, 28 days
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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. |
Baseline, 28 days
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Change in Percentage of Basophilic Granulocytes in White Blood Cell Count
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Hematocrit
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Hemoglobin
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Percentage of Lymphocytes in White Blood Cell Count
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Percentage of Monocytes in White Blood Cell Count
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Platelet Count
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Red Blood Cell Count
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in White Blood Cell Count
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Albumin
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Alkaline Phosphatase
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Blood Urea Nitrogen
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Calcium
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Chloride
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Creatinine
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Gamma-Glutamyltransferase
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Glucose
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Inorganic Phosphate
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Potassium
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Serum Glutamic Oxaloacetic Transaminase
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Glutamic Pyruvic Transaminase
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Sodium
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Total Bilirubin
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Total Protein
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Uric Acid
Lasso di tempo: Baseline, 28 days
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Change = 28 day value minus baseline value.
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Baseline, 28 days
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Ears, Eyes, Nose, Mouth, Throat'
Lasso di tempo: 28 days
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28 days
|
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Psychiatric'
Lasso di tempo: 28 days
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28 days
|
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hematological/Lymphatic Nodes'
Lasso di tempo: 28 days
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28 days
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Dermatological'
Lasso di tempo: 28 days
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28 days
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Cardiovascular'
Lasso di tempo: 28 days
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28 days
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Peripheral Vascular'
Lasso di tempo: 28 days
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28 days
|
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Pulmonary'
Lasso di tempo: 28 days
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28 days
|
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Musculoskeletal'
Lasso di tempo: 28 days
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28 days
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hepato-/Gastrointestinal'
Lasso di tempo: 28 days
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28 days
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Renal/Genitourological'
Lasso di tempo: 28 days
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28 days
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Metabolic/Endocrine'
Lasso di tempo: 28 days
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28 days
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Other'
Lasso di tempo: 28 days
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28 days
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Mental Status'
Lasso di tempo: 28 days
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28 days
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Deep Tendon Reflexes'
Lasso di tempo: 28 days
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28 days
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Muscle Strength'
Lasso di tempo: 28 days
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28 days
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Cranial Nerve Function'
Lasso di tempo: 28 days
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28 days
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Plantar Reflex'
Lasso di tempo: 28 days
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28 days
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Gait'
Lasso di tempo: 28 days
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28 days
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Coordination/Balance'
Lasso di tempo: 28 days
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28 days
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Involuntary Movements'
Lasso di tempo: 28 days
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28 days
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Sensory Perception'
Lasso di tempo: 28 days
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28 days
|
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Other'
Lasso di tempo: 28 days
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28 days
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Completion of Trial From Baseline to End of Treatment
Lasso di tempo: Baseline, 28 days
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Baseline, 28 days
|
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Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment
Lasso di tempo: Baseline, 28 days
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Baseline, 28 days
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Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs)
Lasso di tempo: Baseline, 2 days
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Baseline, 2 days
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Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period
Lasso di tempo: Baseline, 56 days
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Baseline, 56 days
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Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs)
Lasso di tempo: Baseline, 2 days
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Baseline, 2 days
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Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period
Lasso di tempo: Baseline, 56 days
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Baseline, 56 days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment
Lasso di tempo: Baseline, 28 days
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The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part I measures 'Mentation, Behavior and Mood'.
Range: 0 (Best score possible) to 16 (Worst score possible) Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment
Lasso di tempo: Baseline, 28 days
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The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part II measures 'Activities in Daily Living'.
Range: 0 (Best score possible) to 52 (Worst score possible) Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment
Lasso di tempo: Baseline, 28 days
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The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part III measures 'Motor Examination'.
Range: 0 (Best score possible) to 56 (Worst score possible) Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment
Lasso di tempo: Baseline, 28 days
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The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part IV measures 'Complications of Therapy'.
Range: 0 (Best score possible) to 23 (Worst score possible) Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Parkinson's Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment
Lasso di tempo: Baseline, 28 days
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The PDSS is a scale to assess sleep and nocturnal disability in Parkinson's disease. Range: 0 (Best score possible) to 60 (Worst score possible) Change = 28 day value minus baseline value. |
Baseline, 28 days
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Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment
Lasso di tempo: Baseline, 28 days
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The ESS is a self-administered questionnaire in which the subject rates the probability of his/her dozing during 8 situations that are differently conductive to sleep Range: 0 (Best score possible) to 24 (Worst score possible) Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Parkinson's Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment
Lasso di tempo: Baseline, 28 days
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The PDNMS is a rating by the clinician to assess the severity and frequency of non-motor symptoms in Parkinson's disease patients Range: 0 (Best score possible) to 384 (Worst score possible) Change = 28 day value minus baseline value.
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Baseline, 28 days
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Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment
Lasso di tempo: Baseline, 28 days
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The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 1 measures 'Severity of Parkinson's Disease'. Range: 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients) Change = 28 day value minus baseline value. |
Baseline, 28 days
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Clinical Global Impression (CGI) Item 2 Score
Lasso di tempo: 28 days
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The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 2 measures 'Global Improvement'. Range 1 (Very much improved) to 7 (Very much worse) |
28 days
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Clinical Global Impression (CGI) Item 3.1
Lasso di tempo: 28 days
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The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 3.1 measures 'Therapeutic Effect'. Range: 1 (Marked - Vast improvement. Complete or nearly complete remission of all symptoms.) to 4 (Unchanged or worse) |
28 days
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Clinical Global Impression (CGI) Item 3.2
Lasso di tempo: 28 days
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The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 3.2 measures 'Therapeutic Side Effects'. Range: 1 (None) to 4 (Outweigh the therapeutic effect) |
28 days
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Patient Global Impression (PGI) Item 1 Score
Lasso di tempo: 28 days
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The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 1 measures 'Global Improvement'. Range: 1 (Very much improved) to 7 (Very much worse) |
28 days
|
Patient Global Impression (PGI) Item 2
Lasso di tempo: 28 days
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The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 2 measures 'Therapeutic Effect'. Range: 1 (Marked - Vast improvement. Complete or nearly complete remission of all symptoms) to 4 (Unchanged or worse) |
28 days
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Patient Global Impression (PGI) Item 3
Lasso di tempo: 28 days
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The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 3 measures 'Side Effects'. Range: 1 (I have no side effects) to 4 (They outweigh the therapeutic effect of the trial medication) |
28 days
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Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment
Lasso di tempo: Baseline, 28 days
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The PDQ-8 is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease. Range: 0 (good health) to 100 (poor health) Change = 28 day value minus baseline value. |
Baseline, 28 days
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Patient Treatment Preference Scale Question 1
Lasso di tempo: 28 days
|
Have you used pharmaceutical treatments for your Parkinson's disease before the study?
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28 days
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Patient Treatment Preference Scale Question 2
Lasso di tempo: 28 days
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Why did you decide to enter this study?
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28 days
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Patient Treatment Preference Scale Question 3
Lasso di tempo: 28 days
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In comparing the patch and previous oral treatments for Parkinson's disease, how satisfied have you been with oral medication / patch?
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28 days
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Patient Treatment Preference Scale Question 4
Lasso di tempo: 28 days
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I would prefer using a patch over taking a pill or capsule for treatment of my Parkinson's disease.
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28 days
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Patient Treatment Preference Scale Question 5
Lasso di tempo: 28 days
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I would prefer applying one 40cm**2 patch over applying two 20cm**2 patches for treatment of my Parkinson's disease.
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28 days
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Patient Treatment Preference Scale Question 6
Lasso di tempo: 28 days
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What aspects do you like the most about the patch?
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28 days
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Patient Treatment Preference Scale Question 7
Lasso di tempo: 28 days
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What aspects do you like the least about the patch?
Check all that apply.
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28 days
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Malattie parkinsoniane
- Malattie dei gangli basali
- Disturbi del movimento
- Sinucleinopatie
- Malattie Neurodegenerative
- Morbo di Parkinson
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Agonisti della dopamina
- Agenti dopaminergici
- Rotigotina
Altri numeri di identificazione dello studio
- SP0908
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .