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

October 17, 2014 updated by: UCB Pharma

Double-blind, Randomized, Placebo- and Positive-controlled, Parallel-group Trial to Assess the Potential Electrocardiographic Effects of Rotigotine Transdermal System up to 120 cm2/54.0 mg/Day in Subjects With Advanced-stage Idiopathic Parkinson's Disease: A Thorough QT/QTc Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Bloemfontein, South Africa
        • Farmovs-Parexel (Pty) Ltd
      • George, South Africa
        • Qdot, a division of Parexel International DA (Pty) Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rotigotine
Rotigotine Patch
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 Names:
  • Neupro
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
Placebo Comparator: Placebo
Placebo patch
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI at Time of Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 20:00h, Day 42 20:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.
Baseline (Day -2/ Day -1) 20:00h, Day 42 20:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 1 Hour After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 21:00h, Day 42 21:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 21:00h.
Baseline (Day -2/ Day -1) 21:00h, Day 42 21:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 2 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 22:00h, Day 42 22:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 22:00h.
Baseline (Day -2/ Day -1) 22:00h, Day 42 22:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 3 Hours After Patch Application on Day 42(Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 23:00h, Day 42 23:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 23:00h.
Baseline (Day -2/ Day -1) 23:00h, Day 42 23:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 4 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 00:00h, Day 43 00:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 00:00h.
Baseline (Day -2/ Day -1) 00:00h, Day 43 00:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 5 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 1:00h, Day 43 1:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 1:00h.
Baseline (Day -2/ Day -1) 1:00h, Day 43 1:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 6 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 2:00h, Day 43 2:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 2:00h.
Baseline (Day -2/ Day -1) 2:00h, Day 43 2:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 7 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 3:00h, Day 43 3:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 3:00h.
Baseline (Day -2/ Day -1) 3:00h, Day 43 3:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 8 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 4:00h, Day 43 4:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 4:00h.
Baseline (Day -2/ Day -1) 4:00h, Day 43 4:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 9 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 5:00h, Day 43 5:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 5:00h.
Baseline (Day -2/ Day -1) 5:00h, Day 43 5:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 10 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 6:00h, Day 43 6:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 6:00h.
Baseline (Day -2/ Day -1) 6:00h, Day 43 6:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 11 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 7:00h, Day 43 7:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 7:00h.
Baseline (Day -2/ Day -1) 7:00h, Day 43 7:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 12 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 8:00h, Day 43 8:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 8:00h.
Baseline (Day -2/ Day -1) 8:00h, Day 43 8:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 13 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 9:00h, Day 43 9:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 9:00h.
Baseline (Day -2/ Day -1) 9:00h, Day 43 9:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 14 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 10:00h, Day 43 10:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 10:00h.
Baseline (Day -2/ Day -1) 10:00h, Day 43 10:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 15 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 11:00h, Day 43 11:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 11:00h.
Baseline (Day -2/ Day -1) 11:00h, Day 43 11:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 16 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 12:00h, Day 43 12:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 12:00h.
Baseline (Day -2/ Day -1) 12:00h, Day 43 12:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 17 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 13:00h, Day 43 13:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 13:00h.
Baseline (Day -2/ Day -1) 13:00h, Day 43 13:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 18 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 14:00h, Day 43 14:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 14:00h.
Baseline (Day -2/ Day -1) 14:00h, Day 43 14:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 19 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 15:00h, Day 43 15:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 15:00h.
Baseline (Day -2/ Day -1) 15:00h, Day 43 15:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 20 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 16:00h, Day 43 16:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 16:00h.
Baseline (Day -2/ Day -1) 16:00h, Day 43 16:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 21 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 17:00h, Day 43 17:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 17:00h.
Baseline (Day -2/ Day -1) 17:00h, Day 43 17:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 22 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 18:00h, Day 43 18:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 18:00h.
Baseline (Day -2/ Day -1) 18:00h, Day 43 18:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 23 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 19:00h, Day 43 19:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 19:00h.
Baseline (Day -2/ Day -1) 19:00h, Day 43 19:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 24 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)
Time Frame: Baseline (Day -2/ Day -1) 20:00h, Day 43 20:00h
Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.
Baseline (Day -2/ Day -1) 20:00h, Day 43 20:00h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 2 Hours Before Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)
Time Frame: Baseline (Day -2/ Day -1) 8:00h, Day 32/ Day 39 8:00h
Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 8:00h.
Baseline (Day -2/ Day -1) 8:00h, Day 32/ Day 39 8:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 1 Hour Before Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)
Time Frame: Baseline (Day -2/ Day -1) 9:00h, Day 32/ Day 39 9:00h
Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 9:00h.
Baseline (Day -2/ Day -1) 9:00h, Day 32/ Day 39 9:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI at Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)
Time Frame: Baseline (Day -2/ Day -1) 10:00h, Day 32/ Day 39 10:00h
Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 10:00h.
Baseline (Day -2/ Day -1) 10:00h, Day 32/ Day 39 10:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 1 Hour After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)
Time Frame: Baseline (Day -2/ Day -1) 11:00h, Day 32/ Day 39 11:00h
Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 11:00h.
Baseline (Day -2/ Day -1) 11:00h, Day 32/ Day 39 11:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 2 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)
Time Frame: Baseline (Day -2/ Day -1) 12:00h, Day 32/ Day 39 12:00h
Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 12:00h.
Baseline (Day -2/ Day -1) 12:00h, Day 32/ Day 39 12:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 3 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)
Time Frame: Baseline (Day -2/ Day -1) 13:00h, Day 32/ Day 39 13:00h
Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 13:00h.
Baseline (Day -2/ Day -1) 13:00h, Day 32/ Day 39 13:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 4 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)
Time Frame: Baseline (Day -2/ Day -1) 14:00h, Day 32/ Day 39 14:00h
Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 14:00h.
Baseline (Day -2/ Day -1) 14:00h, Day 32/ Day 39 14:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 5 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)
Time Frame: Baseline (Day -2/ Day -1) 15:00h, Day 32/ Day 39 15:00h
Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 15:00h.
Baseline (Day -2/ Day -1) 15:00h, Day 32/ Day 39 15:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 6 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)
Time Frame: Baseline (Day -2/ Day -1) 16:00h, Day 32/ Day 39 16:00h
Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 16:00h.
Baseline (Day -2/ Day -1) 16:00h, Day 32/ Day 39 16:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 7 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)
Time Frame: Baseline (Day -2/ Day -1) 17:00h, Day 32/ Day 39 17:00h
Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 17:00h.
Baseline (Day -2/ Day -1) 17:00h, Day 32/ Day 39 17:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 8 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)
Time Frame: Baseline (Day -2/ Day -1) 18:00h, Day 32/ Day 39 18:00h
Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 18:00h.
Baseline (Day -2/ Day -1) 18:00h, Day 32/ Day 39 18:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 9 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)
Time Frame: Baseline (Day -2/ Day -1) 19:00h, Day 32/ Day 39 19:00h
Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 19:00h.
Baseline (Day -2/ Day -1) 19:00h, Day 32/ Day 39 19:00h
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 10 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)
Time Frame: Baseline (Day -2/ Day -1) 20:00h, Day 32/ Day 39 20:00h
Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.
Baseline (Day -2/ Day -1) 20:00h, Day 32/ Day 39 20:00h

Collaborators and Investigators

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Sponsor

UCB Pharma

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Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

February 14, 2006

First Submitted That Met QC Criteria

February 14, 2006

First Posted (Estimate)

February 15, 2006

Study Record Updates

Last Update Posted (Estimate)

October 27, 2014

Last Update Submitted That Met QC Criteria

October 17, 2014

Last Verified

February 1, 2011

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Other Study ID Numbers

  • SP0864

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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