A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery

Parkinson's Disease Clinical Trial

— NEUPOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594464
• Other study ID #: SP0882
• Secondary ID: 2006-005438-19
• Status: Completed
• Phase: Phase 4
• First received: December 21, 2007
• Last updated: September 24, 2014
• Start date: September 2007
• Est. completion date: May 2008

Study information

• Verified date: December 2010
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Rotigotine
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Wüllner U, Kassubek J, Odin P, Schwarz M, Naumann M, Häck HJ, Boroojerdi B, Reichmann H; NEUPOS Study Group. Transdermal rotigotine for the perioperative management of Parkinson's disease. J Neural Transm (Vienna). 2010 Jul;117(7):855-9. doi: 10.1007/s007 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist.	Questionnaire including 4 items Range of sum score: 4 to 24 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Patient did not show unexpected symptoms Item 2: Handling was simple Item 3: Handling wasn't time-consuming Item 4: Patch is a considerable option	After subject wakes up from general anesthesia	No
Primary	Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Neurologist.	Questionnaire including 4 items Range of sum score: 4 to 24 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Switch to patch was easily feasible Item 2: Re-switch was easily feasible Item 3: Patient did not show unexpected symptoms Item 4: Patch is a feasible option	2 weeks after surgery	No
Primary	Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Patient.	Questionnaire including 3 items Range of sum score: 3 to 18 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Therapy with patch was easily feasible Item 2: Symptoms of Parkinson's Disease were well controlled Item 3: I felt safe with the Parkinson patch	2 weeks after surgery	No
Secondary	Plasma Concentration of Rotigotine After Use.		24 hours	No

External Links

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