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

NCT00292227 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2014-10-27

Study results available
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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.

Conditions

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

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2006-09-30
Completion
2006-10-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00292227 on ClinicalTrials.gov