Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease Patients
NCT ID: NCT01646268
Last Updated: 2015-08-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
249 participants
INTERVENTIONAL
2012-07-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Rotigotine
Rotigotine, daily doses, treatment group
Rotigotine
Transdermal Patch
Content:
2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2)
For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period
Placebo
Placebo, daily doses, placebo group
Placebo Patch
Transdermal Patch
Size:
10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2
Subjects randomized to placebo will receive matching placebo patches
Interventions
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Rotigotine
Transdermal Patch
Content:
2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2)
For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period
Placebo Patch
Transdermal Patch
Size:
10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2
Subjects randomized to placebo will receive matching placebo patches
Eligibility Criteria
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Inclusion Criteria
* Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule or study medication intake according to the judgment of the investigator
* Subject has Idiopathic Parkinson's Disease of ≤5 years' duration, defined by the cardinal sign, Bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, or impairment of postural reflexes, and without any other known or suspected cause of Parkinsonism
* Subject is Hoehn \& Yahr stage ≤3
* Subject is male or female aged ≥30 years at Screening (Visit 1)
* Subject has a Mini Mental State Examination (MMSE) score of ≥25
* Subject has a Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III) of ≥10 at Baseline (Visit 2)
* If the subject is receiving an Anticholinergic agent (eg, Benztropine, Trihexyphenidyl, Parsitan, Procyclidine, Biperiden), a monoamine oxidase (MAO)-B inhibitor (eg, Selegiline), 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 Baseline (Visit 2) and be maintained on that dose for the duration of the study
Exclusion Criteria
* Subject is participating in another study of an investigational drug or has done so within 28 days prior to the Baseline Visit (Visit 2)
* Subject has a history of significant skin hypersensitivity to adhesive or other transdermal preparations or recent unresolved contact Dermatitis
* Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1)
* Subject has atypical Parkinson's syndrome(s) due to drugs (eg, Metoclopramide, Flunarizine), metabolic neurogenetic disorders (eg, Wilson's Disease), Encephalitis, Cerebrovascular Disease, or Degenerative Disease (eg, progressive Supranuclear Palsy)
* Subject has a history of Pallidotomy, Thalamotomy, deep brain stimulation, or fetal tissue transplant
* Subject has dementia, active psychosis or hallucinations, or severe depression
* Subject is receiving therapy with a dopamine agonist either concurrently or has done so within 28 days prior to the Baseline Visit (Visit 2)
* Subject is receiving therapy with L dopa/carbidopa and/or L-dopa/benserazide within 28 days of Baseline (Visit 2) or has received L-dopa/carbidopa and/or L-dopa/benserazide for more than 6 months since diagnosis
* Subject is receiving therapy with 1 of the following drugs either concurrently or within 28 days prior to Baseline (Visit 2): Alpha-methyl dopa, Metoclopramide, Reserpine, Neuroleptics (except specific atypical neuroleptics: Olanzapine, Ziprasidone, Aripiprazole, Clozapine, Quetiapine), 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 Baseline Visit (Visit 2) and is likely to remain stable for the duration of the study
* Subject has a current diagnosis of Epilepsy, has a history of seizures as an adult, has a history of stroke, or has had a transient ischemic attack within 1 year prior to Screening (Visit 1)
* Subject has clinically relevant hepatic dysfunction (as defined as a total bilirubin \>2.0 mg/dL or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 2 times the upper limit of the reference range)
* Subject has clinically relevant renal dysfunction (serum creatinine \>2.0 mg/dL \[\>178 umol/L\])
* Subject has clinically relevant cardiac dysfunction (any cardiac disorder which in the opinion of the investigator would put the subject at risk of clinically relevant arrhythmia) and/or myocardial infarction within the last 12 months
* Subject has a QT interval corrected for heart rate according to Bazett's formula (QTcB) of ≥500 ms at Screening (Visit 1)
* Subject has a history of only symptomatic (not asymptomatic) orthostatic hypotension with a decrease of systolic blood pressure (SBP) from supine to standing position of ≥20 mmHg or of ≥10 mmHg in diastolic blood pressure (DBP) after 1 or 3 minutes within 28 days prior to the Baseline Visit (Visit 2), or SBP less than 105 mmHg at study entry
* Subject has evidence of an impulse control disorder (ICD) at Screening (Visit 1)
* Subject has a history of known intolerance/hypersensitivity to the following Antiemetics; Domperidone, Trimethobenzamide, Ondansetron, Tropisetron, Granisetron, and Glycopyrrolate
* Subject has a history of chronic alcohol or drug abuse within the last 5 years
* 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 a double barrier method) or (iii) not sexually abstinent or (iv) not at least 2 years post-menopausal
* Subject has any other clinically relevant medical condition, psychiatric condition, or laboratory abnormality, which would in the judgment of the investigator, interfere with the subject's ability to participate in the study
30 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
1 877 822 9493
Locations
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001
Beijing, , China
002
Beijing, , China
019
Beijing, , China
025
Beijing, , China
017
Changchun, , China
007
Chengdu, , China
027
Chengdu, , China
021
Fuzhou, , China
010
Guangzhou, , China
011
Guangzhou, , China
014
Guangzhou, , China
015
Guangzhou, , China
005
Hangzhou, , China
013
Hangzhou, , China
018
Hangzhou, , China
023
Jinan, , China
003
Shanghai, , China
004
Shanghai, , China
009
Shanghai, , China
008
Suzhou, , China
016
Tianjin, , China
006
Wuhan, , China
022
Wuhan, , China
024
Wuhan, , China
Countries
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Other Identifiers
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SP0914
Identifier Type: -
Identifier Source: org_study_id
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