Phase 1
N=130
Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's Disease
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00292227 ↗Enrolled (actual)
130
Serious AEs
0.8%
Results posted
Feb 2010
Primary outcome: Primary: 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) — 0.46; 1.13 milliseconds [ms]
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Rotigotine (Drug); Placebo (Other); Moxifloxacin infusion (Drug); Placebo infusion (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Sep 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
0.46; 1.13 | — |
| PRIMARY 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) |
1.82; 1.67 | — |
| PRIMARY 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) |
2.55; 1.78 | — |
| PRIMARY 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) |
1.02; 0.89 | — |
| PRIMARY 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) |
0.54; 0.83 | — |
| PRIMARY 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) |
-0.17; 0.03 | — |
| PRIMARY 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) |
-0.62; 0.05 | — |
| PRIMARY 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) |
-0.63; -0.26 | — |
| PRIMARY 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) |
-0.31; 0.95 | — |
| PRIMARY 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) |
-0.39; -1.97 | — |
| PRIMARY 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) |
0.92; 0.58 | — |
| PRIMARY 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) |
1.94; 0.30 | — |
| PRIMARY 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) |
1.16; 1.31 | — |
| PRIMARY 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) |
0.83; 1.40 | — |
| PRIMARY 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) |
1.83; 2.12 | — |
| PRIMARY 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) |
1.15; 1.60 | — |
| PRIMARY 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) |
2.21; 1.99 | — |
| PRIMARY 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) |
1.35; 2.59 | — |
| PRIMARY 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) |
-0.31; 1.29 | — |
| PRIMARY 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) |
0.71; 1.51 | — |
| PRIMARY 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) |
1.58; 1.90 | — |
| PRIMARY 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) |
-0.13; 0.57 | — |
| PRIMARY 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) |
1.45; 0.27 | — |
| PRIMARY 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) |
1.50; 0.64 | — |
| PRIMARY 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) |
-0.96; -0.58 | — |
| SECONDARY 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) |
1.70; 1.29 | — |
| SECONDARY 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) |
1.84; 1.36 | — |
| SECONDARY 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) |
2.21; 0.82 | — |
| SECONDARY 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) |
17.19; 3.70 | — |
| SECONDARY 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) |
12.44; 1.42 | — |
| SECONDARY 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) |
12.68; 1.44 | — |
| SECONDARY 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) |
9.48; 1.28 | — |
| SECONDARY 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) |
10.06; 0.08 | — |
| SECONDARY 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) |
9.98; 1.10 | — |
| SECONDARY 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) |
8.97; 0.37 | — |
| SECONDARY 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) |
7.74; 0.22 | — |
| SECONDARY 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) |
7.33; -0.25 | — |
| SECONDARY 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) |
6.34; 0.14 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00292227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.