Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's Disease

PHASE1CompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

September 30, 2006

Study Completion Date

October 31, 2006

Conditions
Parkinson's Disease
Interventions
DRUG

Rotigotine

"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;"

OTHER

Placebo

"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;"

DRUG

Moxifloxacin infusion

Moxifloxacin 400 mg/250 mL iv solution infused over 1h once either on Day 32 or on Day 39

OTHER

Placebo infusion

Placebo saline solution 250 mL infused over 1h once either on Day 32 or on Day 39

OTHER

Placebo infusion

Placebo saline solution 250 mL infused over 1h once on both Day 32 and on Day 39

Trial Locations (2)

Unknown

Farmovs-Parexel (Pty) Ltd, Bloemfontein

Qdot, a division of Parexel International DA (Pty) Ltd., George

Sponsors

Lead Sponsor

All Listed Sponsors
lead

UCB Pharma

INDUSTRY

NCT00292227 - Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's Disease | Biotech Hunter | Biotech Hunter