Safety and Tolerability Trial of Switching From Ropinirole to Rotigotine
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Rotigotine
Intervention description: Strength: 2,4,6,and 8mg/24h, form: transdermal application, once daily application
Intervention MeSH terms: Rotigotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rotigotine; NEUPRO; Switching trial from ropinirole to rotigotine,; safety and tolerability; Parkinson disease

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
    

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.

          -  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.