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OpenTrials
Completed

NCT Number: NCT00292227

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Farmovs-Parexel (Pty) Ltd, Bloemfontein, South Africa

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rotigotine

Drug

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

Placebo

Other

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 infusion

Drug

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

placebo infusion

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

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.

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Feb 15, 2006
Registry last updated
Oct 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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