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

NCT00594464 | Completed Phase 4 Results

• 2 other identifiers: SP08822006-005438-19
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 12

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

Keywords

Rotigotine; NEUPRO®; Parkinson's Disease (PD); perioperative use; anaesthesia,

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (1)

• Plasma Concentration of Rotigotine After Use.

  24 hours

Study Arms (1)

1

EXPERIMENTAL

Rotigotine

Drug: Rotigotine

Interventions

Rotigotine 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.

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (12)

Unknown Facility

Augsburg, Germany

Location

Unknown Facility

Bochum, Germany

Location

Unknown Facility

Bonn, Germany

Location

Unknown Facility

Bremerhaven, Germany

Location

Unknown Facility

Dortmund, Germany

Location

Unknown Facility

Dresden, Germany

Location

Unknown Facility

Hanau, Germany

Location

Unknown Facility

Ingolstadt, Germany

Location

Unknown Facility

Kiel, Germany

Location

Unknown Facility

Schwerin, Germany

Location

Unknown Facility

Stralsund, Germany

Location

Unknown Facility

Ulm, Germany

Location

Related Publications (1)

• 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.

  PMID: 20535621 RESULT

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Parkinson Disease

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB Pharma

+1 877 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 15, 2008
• Study Start: September 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: October 2, 2014
• Results First Posted: July 3, 2009

Record last verified: 2010-12

Locations

DE (12)