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

NCT ID: NCT00594464

Last Updated: 2014-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-05-31

Brief 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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Rotigotine

Group Type: EXPERIMENTAL

Rotigotine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

Augsburg, , Germany

Bochum, , Germany

Bonn, , Germany

Bremerhaven, , Germany

Dortmund, , Germany

Dresden, , Germany

Hanau, , Germany

Ingolstadt, , Germany

Kiel, , Germany

Schwerin, , Germany

Stralsund, , Germany

Ulm, , Germany

Countries

Germany

References

Wullner U, Kassubek J, Odin P, Schwarz M, Naumann M, Hack 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/s00702-010-0425-4. Epub 2010 Jun 10.

Reference Type: RESULT

PMID: 20535621 (View on PubMed)

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

2006-005438-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP0882

Identifier Type: -

Identifier Source: org_study_id