Conditions: Parkinson's Disease
Keywords: advanced-stage idiopathic Parkinson's disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 130
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Rotigotine Patch arm 2: Placebo patch

Interventions: intervention 1: Rotigotine intervention 2: Placebo intervention 3: Moxifloxacin infusion intervention 4: Placebo infusion intervention 5: Placebo infusion
Intervention descriptions: intervention 1: 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; intervention 2: 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; intervention 3: Moxifloxacin 400 mg/250 mL iv solution infused over 1h once either on Day 32 or on Day 39 intervention 4: Placebo saline solution 250 mL infused over 1h once either on Day 32 or on Day 39 intervention 5: Placebo saline solution 250 mL infused over 1h once on both Day 32 and on Day 39

Protocol document: