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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Rotigotine

Rotigotine Patch

Group Type EXPERIMENTAL

Rotigotine

Intervention Type 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;

Placebo infusion

Intervention Type OTHER

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

Placebo

Placebo patch

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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

Intervention Type DRUG

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

Placebo infusion

Intervention Type OTHER

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

Interventions

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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;

Intervention Type DRUG

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;

Intervention Type OTHER

Moxifloxacin infusion

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

Intervention Type DRUG

Placebo infusion

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

Intervention Type OTHER

Placebo infusion

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

Intervention Type OTHER

Other Intervention Names

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Neupro

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No