Phase 4
Completed N=14
A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery
Source: ClinicalTrials.gov NCT00594464 ↗Enrolled (actual)
14
Serious AEs
28.6%
Results posted
Jul 2009
Primary outcomePrimary: Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist. — 5.0 Score on scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist. |
5.0 | — |
| PRIMARY Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Neurologist. |
5.2 | — |
| PRIMARY Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Patient. |
3.9 | — |
| SECONDARY Plasma Concentration of Rotigotine After Use. |
0.1640; 0.2480; 0.7570; 0.8405; 0.8689; 1.6958 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has idiopathic Parkinson's disease (early- or advanced-stage), as defined by the cardinal sign bradykinesia, plus the presence of at least one of the following: resting tremor, rigidity, or postural instability and is without any other known or suspected cause of Parkinsonism.
- Subject is scheduled for an operation requiring general anesthesia.
Exclusion Criteria
- Subject has previously been treated with rotigotine.
- Subject has a history of significant skin hypersensitivity to adhesives or other transdermals or recent unresolved contact dermatitis or has a known allergy or hypersensitivity to rotigotine or to other components of the patch.
- Subject is scheduled for a surgical procedure (surgery per protocol(SPP)) that requires magnetic resonance imaging or cardioversion.
- Subject has a high probability to require extended postoperative ventilation (> 24 hours).
- Subject has any medical condition that, in the opinion of the investigator, could jeopardize or compromise the subject's ability to participate in this trial.
Data sourced from ClinicalTrials.gov (NCT00594464). 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. Informational only — not medical advice.