CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 14 enrolled
Drug / intervention
Rotigotinedrug
Likely dose
Rotigotine 2–16 mg/24 h transdermal patch, dosed perioperatively based on patient's established regimenAI-extracted
Key inclusion· 2
  • ✓Confirmed idiopathic Parkinson's disease (early- or advanced-stage) with bradykinesia as cardinal sign plus at least one of: resting tremor, rigidity, or postural instability, without other known cause of Parkinsonism.
  • ✓Scheduled for surgical procedure requiring general anesthesia.
Key exclusion· 4
  • ✕Prior treatment with rotigotine.
  • ✕History of significant skin hypersensitivity to adhesives, transdermals, contact dermatitis, or known allergy/hypersensitivity to rotigotine or patch components.
  • ✕Surgical procedure requiring magnetic resonance imaging or cardioversion.
  • ✕High probability of requiring extended postoperative ventilation (>24 hours).

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

Search/NCT00594464
NCT00594464Phase 4Completed
CompareCT.gov

An Explorative, Multicenter, Open-label Pilot Trial With Neupro® (Rotigotine Transdermal Patch) Once Daily Treatment Administered Perioperatively in Patients With Idiopathic Parkinson's Disease

UCB Pharma·interventional·Posted Jan 15, 2008·Updated Oct 2, 2014

In Brief

A Phase 4 clinical trial evaluating Rotigotine for Parkinson's Disease. Completed, enrolled 14 participants across 12 sites.

Detailed Summary

Evaluation of efficacy and safety on the use of rotigotine in patients suffering from Parkinson's Disease during and after surgery requiring general anaesthesia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesGermany
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 15, 2008
Enrollment StartSep 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.5 years ago

Interventions

Rotigotinedrug

2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h patch; Single patches and a combination of 2 of these patches for a dosage of up to 16 mg/24 h; One (1) regimen on day of surgery, but exceptionally extended for up to 2 (two) weeks if the patient requires unexpected ventilation after surgery.