CompletedPhase 1

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

South Africa130 participantsStarted 2006-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, reserpin…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: Baseline (Day -2/ Day -1) 00:00h, Day 43 00:00h

Trial details

NCT IDNCT00292227

SponsorUCB Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-09

Results submitted2009-09-09

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