Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Rotigotine; Placebo; Moxifloxacin infusion; Placebo infusion; Placebo infusion
Intervention description: Rotigotine patch applied once daily for a 24-hour period.
Rotigotine dose schedule (patch application days):
Day 1 through Day 7: 9.0 mg/day; Day 8 through Day 14: 18.0 mg/day; Day 15 through Day 21: 27.0 mg/day; Day 22 through Day 28: 36.0 mg/day; Day 29 through Day 35: 45.0 mg/day; Day 36 through Day 42: 54.0 mg/day; Day 43 through Day 44: 45.0 mg/day; Day 45 through Day 46: 36.0 mg/day; Day 47 through Day 48: 27.0 mg/day; Day 49 through Day 50: 18.0 mg/day; Day 51 through Day 52: 9.0 mg/day;; Placebo patch applied once daily for a 24-hour period. Size and number of patches matching to rotigotine dose schedule (patch application days):
Day 1 through Day 7: 9.0 mg/day; Day 8 through Day 14: 18.0 mg/day; Day 15 through Day 21: 27.0 mg/day; Day 22 through Day 28: 36.0 mg/day; Day 29 through Day 35: 45.0 mg/day; Day 36 through Day 42: 54.0 mg/day; Day 43 through Day 44: 45.0 mg/day; Day 45 through Day 46: 36.0 mg/day; Day 47 through Day 48: 27.0 mg/day; Day 49 through Day 50: 18.0 mg/day; Day 51 through Day 52: 9.0 mg/day;; Moxifloxacin 400 mg/250 mL iv solution infused over 1h once either on Day 32 or on Day 39; Placebo saline solution 250 mL infused over 1h once either on Day 32 or on Day 39; Placebo saline solution 250 mL infused over 1h once on both Day 32 and on Day 39
Intervention MeSH terms: Moxifloxacin; Rotigotine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: advanced-stage idiopathic Parkinson's disease

Summary:

      The purpose of this trial is to assess whether rotigotine has an effect on the electrical
      activity of the heart. Moxifloxacin infusion is used as positive control to assess assay
      sensitivity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 18 years of age

          -  Advanced-stage idiopathic Parkinson's disease requiring treatment with levodopa.

          -  Nonchildbearing potential

        Exclusion Criteria:

          -  Atypical Parkinson's syndrome(s).

          -  History of pallidotomy, thalamotomy, deep brain stimulation, or fetal tissue
             transplant.

          -  Significant tremor or dyskinesias.

          -  Severe dysfunction of the autonomic nervous system.

          -  History of transient ischemic attack or stroke within the last 12 months.

          -  Conduction abnormality or relevant cardiac dysfunction and/or myocardial infarction
             within last 12 months.

          -  History or current condition of additional risk factors for Torsade de Pointes (eg,
             heart failure, hypokalemia), or a family history of long QT syndrome and/or of Torsade
             de Pointes.

          -  No stable sinus rhythm: more than 20 ectopics/h.

          -  Any other clinically relevant ECG abnormality.

          -  History or current condition of epilepsy and/or seizures.

          -  History or current condition of atopic or eczematous dermatitis, psoriasis, or another
             active skin disease.

          -  History or current condition of symptomatic orthostatic hypotension.

          -  History or current condition of significant skin hypersensitivity to adhesives or
             other transdermal products or recent unresolved contact dermatitis.

          -  History of glucose 6-phosphate dehydrogenase deficiency.

          -  History of tendonitis or tendon rupture with quinolone antibiotics.

          -  Renal or hepatic dysfunction.

          -  Treatment with dopamine agonists, MAO A inhibitors, reserpine, or alpha-methyldopa

          -  Therapy known to produce a nontrivial prolongation of the QT interval.