At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 130 enrolled

Drug / intervention

Rotigotine +4 moredrug

Likely dose

Rotigotine 9.0 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00292227

NCT00292227Phase 1Completed

Compare CT.gov

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.

UCB Pharma·interventional·Posted Feb 15, 2006·Updated Oct 27, 2014

In Brief

A Phase 1 clinical trial evaluating Rotigotine, Placebo, and 2 other interventions for Parkinson's Disease. Completed, enrolled 130 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsParkinson's Disease

CountriesSouth Africa

Collaborators--

Timeline

Phase 1CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJan 2006

First PostedFeb 2006

Primary CompletionSep 2006

Study CompletionOct 2006

TodayJul 2026

First PostedFeb 15, 2006

Enrollment StartJan 1, 2006

Primary CompletionSep 1, 2006

Study CompletionOct 1, 2006

TodayJul 2, 2026

Enrollment to primary: 8 monthsPosted 20.4 years ago

Interventions

Rotigotinedrug

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;

Placeboother

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 infusiondrug

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

Placebo infusionother

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

Placebo infusionother

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