Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease Patients
Condition: IDIOPATHIC PARKINSON'S DISEASE
MeSH terms: Parkinson Disease
Intervention: Rotigotine; Placebo Patch
Intervention description: 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; Transdermal Patch
Size:
10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2
Subjects randomized to placebo will receive matching placebo patches
Intervention MeSH terms: Rotigotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 249.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Rotigotine; Neupro phase 3; Early phase; Idiopathic Parkinson's Disease

Summary:

      The primary objective is to demonstrate that the Rotigotine transdermal patch is efficacious
      in Chinese subjects with early-stage idiopathic Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An Independent Ethics Committee (IEC)-approved written informed consent is signed and
             dated by the subject or by the legal representative

          -  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 has previously participated in this study or subject has previously received
             the study medication under investigation in this study

          -  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