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

UCB

Status and phase: Completed; Phase 1

Conditions: Parkinson's Disease

Treatments: Other: Placebo infusion; Other: Placebo; Drug: Rotigotine; Drug: Moxifloxacin infusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00292227

SP0864

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 2 patient groups, including a placebo group

Rotigotine

Experimental group

Description:

Rotigotine Patch

Treatment:

Drug: Rotigotine

Other: Placebo infusion

Other: Placebo infusion

Placebo

Placebo Comparator group

Description:

Placebo patch

Treatment:

Drug: Moxifloxacin infusion

Other: Placebo

Other: Placebo infusion

Other: Placebo infusion