Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 October 2017 |
Main ID: |
NCT00593606 |
Date of registration:
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21/12/2007 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Safety and Tolerability Trial of Switching From Ropinirole to Rotigotine
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Scientific title:
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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 |
Date of first enrolment:
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July 2007 |
Target sample size:
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124 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00593606 |
Study type:
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Interventional |
Study design:
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Phase:
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Phase 3
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Contacts
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Name:
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UCB Clinical Trial Call Center |
Address:
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Telephone:
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Email:
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Affiliation:
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+1 877 822 9493 (UCB) |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Rotigotine
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Primary Outcome(s)
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Change in Blood Urea Nitrogen
[Time Frame: Baseline, 28 days]
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Change in Diastolic Blood Pressure (Supine, After 5 Minutes)
[Time Frame: Baseline, 28 days]
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Change in Hemoglobin
[Time Frame: Baseline, 28 days]
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Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count
[Time Frame: Baseline, 28 days]
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Change in Pulse Rate (Standing, After 3 Minutes)
[Time Frame: Baseline, 28 days]
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Change in Red Blood Cell Count
[Time Frame: Baseline, 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Cranial Nerve Function'
[Time Frame: 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Involuntary Movements'
[Time Frame: 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Dermatological'
[Time Frame: 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Ears, Eyes, Nose, Mouth, Throat'
[Time Frame: 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Other'
[Time Frame: 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Peripheral Vascular'
[Time Frame: 28 days]
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Change in Alkaline Phosphatase
[Time Frame: Baseline, 28 days]
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Change in Calcium
[Time Frame: Baseline, 28 days]
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Change in Chloride
[Time Frame: Baseline, 28 days]
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Change in Glucose
[Time Frame: Baseline, 28 days]
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Change in Diastolic Blood Pressure (Standing, After 1 Minute)
[Time Frame: Baseline, 28 days]
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Change in Gamma-Glutamyltransferase
[Time Frame: Baseline, 28 days]
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Change in Total Protein
[Time Frame: Baseline, 28 days]
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Change in White Blood Cell Count
[Time Frame: Baseline, 28 days]
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Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period
[Time Frame: Baseline, 56 days]
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Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs)
[Time Frame: Baseline, 2 days]
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Deep Tendon Reflexes'
[Time Frame: 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Cardiovascular'
[Time Frame: 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Psychiatric'
[Time Frame: 28 days]
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Change in Creatinine
[Time Frame: Baseline, 28 days]
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Change in Heart Rate
[Time Frame: Baseline, 28 days]
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Change in Hematocrit
[Time Frame: Baseline, 28 days]
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Change in PR Interval
[Time Frame: Baseline, 28 days]
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Change in Pulse Rate (Supine, After 1 Minute)
[Time Frame: Baseline, 28 days]
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Change in QT Interval
[Time Frame: Baseline, 28 days]
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Change in Serum Glutamic Oxaloacetic Transaminase
[Time Frame: Baseline, 28 days]
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Change in Systolic Blood Pressure (Supine, After 1 Minute)
[Time Frame: Baseline, 28 days]
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Change in Uric Acid
[Time Frame: Baseline, 28 days]
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Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs)
[Time Frame: Baseline, 2 days]
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Gait'
[Time Frame: 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Mental Status'
[Time Frame: 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Pulmonary'
[Time Frame: 28 days]
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Change in Diastolic Blood Pressure (Standing, After 3 Minutes)
[Time Frame: Baseline, 28 days]
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Change in Percentage of Basophilic Granulocytes in White Blood Cell Count
[Time Frame: Baseline, 28 days]
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Change in Percentage of Lymphocytes in White Blood Cell Count
[Time Frame: Baseline, 28 days]
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Change in Potassium
[Time Frame: Baseline, 28 days]
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Change in Systolic Blood Pressure (Standing, After 1 Minute)
[Time Frame: Baseline, 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Plantar Reflex'
[Time Frame: 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Sensory Perception'
[Time Frame: 28 days]
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Change in Albumin
[Time Frame: Baseline, 28 days]
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Change in Inorganic Phosphate
[Time Frame: Baseline, 28 days]
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Change in Total Bilirubin
[Time Frame: Baseline, 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Other'
[Time Frame: 28 days]
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Change in Glutamic Pyruvic Transaminase
[Time Frame: Baseline, 28 days]
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Change in Percentage of Monocytes in White Blood Cell Count
[Time Frame: Baseline, 28 days]
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Change in Pulse Rate (Supine, After 5 Minutes)
[Time Frame: Baseline, 28 days]
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Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB)
[Time Frame: Baseline, 28 days]
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Change in Systolic Blood Pressure (Standing, After 3 Minutes)
[Time Frame: Baseline, 28 days]
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Completion of Trial From Baseline to End of Treatment
[Time Frame: Baseline, 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hepato-/Gastrointestinal'
[Time Frame: 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Musculoskeletal'
[Time Frame: 28 days]
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Change in QRS Duration
[Time Frame: Baseline, 28 days]
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Change in Sodium
[Time Frame: Baseline, 28 days]
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Change in Systolic Blood Pressure (Supine, After 5 Minutes)
[Time Frame: Baseline, 28 Days]
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Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment
[Time Frame: Baseline, 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Muscle Strength'
[Time Frame: 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Renal/Genitourological'
[Time Frame: 28 days]
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Change in Diastolic Blood Pressure (Supine, After 1 Minute)
[Time Frame: Baseline, 28 days]
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Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count
[Time Frame: Baseline, 28 days]
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Change in Platelet Count
[Time Frame: Baseline, 28 days]
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Change in Pulse Rate (Standing, After 1 Minute)
[Time Frame: Baseline, 28 days]
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Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period
[Time Frame: Baseline, 56 days]
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Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Coordination/Balance'
[Time Frame: 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hematological/Lymphatic Nodes'
[Time Frame: 28 days]
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Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Metabolic/Endocrine'
[Time Frame: 28 days]
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Secondary Outcome(s)
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Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment
[Time Frame: 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
[Time Frame: Baseline, 28 days]
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Clinical Global Impression (CGI) Item 3.1
[Time Frame: 28 days]
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Change in Parkinson's Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment
[Time Frame: Baseline, 28 days]
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Clinical Global Impression (CGI) Item 3.2
[Time Frame: 28 days]
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Patient Global Impression (PGI) Item 2
[Time Frame: 28 days]
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Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment
[Time Frame: Baseline, 28 days]
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Patient Treatment Preference Scale Question 1
[Time Frame: 28 days]
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Patient Treatment Preference Scale Question 2
[Time Frame: 28 days]
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Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment
[Time Frame: Baseline, 28 days]
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Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment
[Time Frame: Baseline, 28 days]
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Clinical Global Impression (CGI) Item 2 Score
[Time Frame: 28 days]
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Patient Treatment Preference Scale Question 7
[Time Frame: 28 days]
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Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment
[Time Frame: Baseline, 28 days]
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Patient Global Impression (PGI) Item 1 Score
[Time Frame: 28 days]
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Patient Treatment Preference Scale Question 4
[Time Frame: 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
[Time Frame: 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
[Time Frame: Baseline, 28 days]
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Patient Global Impression (PGI) Item 3
[Time Frame: 28 days]
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Patient Treatment Preference Scale Question 3
[Time Frame: 28 days]
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Patient Treatment Preference Scale Question 5
[Time Frame: 28 days]
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Patient Treatment Preference Scale Question 6
[Time Frame: 28 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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