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

• Sponsor: UCB Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00594464
• Collaborator: (none)
• Enrollment: 14
• Locations: 12
• Arm: 1
• Duration (Months): 8
• Patients Per Site: 1.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Rotigotine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Rotigotine	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.

Outcome Measures

Primary Outcome Measures

1. Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist. [After subject wakes up from general anesthesia]

   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

2. Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Neurologist. [2 weeks after surgery]

   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

3. Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Patient. [2 weeks after surgery]

   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

Secondary Outcome Measures

1. Plasma Concentration of Rotigotine After Use. [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Augsburg		Germany
2		Bochum		Germany
3		Bonn		Germany
4		Bremerhaven		Germany
5		Dortmund		Germany
6		Dresden		Germany
7		Hanau		Germany
8		Ingolstadt		Germany
9		Kiel		Germany
10		Schwerin		Germany
11		Stralsund		Germany
12		Ulm		Germany

Sponsors and Collaborators

• UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center, [phone] (UCB)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00594464
• Other Study ID Numbers: SP0882; 2006-005438-19
• First Posted: Jan 15, 2008
• Last Update Posted: Oct 2, 2014
• Last Verified: Dec 1, 2010

• Keywords provided by UCB Pharma: Rotigotine; NEUPRO®; Parkinson's Disease (PD); perioperative use; anaesthesia,
• Additional relevant MeSH terms: Parkinson Disease; Rotigotine

Study Results

Participant Flow

Arm/Group Title	Rotigotine
Arm/Group Description	Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
Period Title: Overall Study
STARTED	14
COMPLETED	11
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Rotigotine
Arm/Group Description	Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
Overall Participants	14
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 14.3%
>=65 years	12 85.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.7 (5.9)
Sex: Female, Male (Count of Participants)
Female	7 50%
Male	7 50%
Region of Enrollment (participants) [Number]
Germany	14 100%

Outcome Measures

1. Primary Outcome

Title	Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist.
Description	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
Time Frame	After subject wakes up from general anesthesia

Outcome Measure Data

Analysis Population Description

Full Analysis Set (Subjects having valid data for all three feasibility assessments)

Arm/Group Title	Rotigotine
Arm/Group Description	Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
Measure Participants	9
Mean (Standard Deviation) [Score on scale]	5.0 (1.8)

2. Secondary Outcome

Title	Plasma Concentration of Rotigotine After Use.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set (Subjects for whom a blood sample for determination of the plasma concentration of rotigotine was drawn and a valid determination of the plasma concentration could be done)

Arm/Group Title	Rotigotine 2 mg/24h	Rotigotine 6mg/24h	Rotigotine 8 mg/24h	Rotigotine 12 mg/24h	Rotigotine 14 mg/24h	Rotigotine 16 mg/24h
Arm/Group Description
Measure Participants	1	1	2	2	1	3
Mean (Standard Deviation) [ng/ml]	0.1640 (0)	0.2480 (0)	0.7570 (0.1569)	0.8405 (0.3302)	0.8689 (0)	1.6958 (2.1951)

3. Primary Outcome

Title	Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Neurologist.
Description	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
Time Frame	2 weeks after surgery

Outcome Measure Data

Analysis Population Description

Full Analysis Set (Subjects having valid data for all three feasibility assessments)

Arm/Group Title	Rotigotine
Arm/Group Description	Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
Measure Participants	9
Mean (Standard Deviation) [Score on scale]	5.2 (2.2)

4. Primary Outcome

Title	Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Patient.
Description	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
Time Frame	2 weeks after surgery

Outcome Measure Data

Analysis Population Description

Full Analysis Set (Subjects having valid data for all three feasibility assessments)

Arm/Group Title	Rotigotine
Arm/Group Description	Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
Measure Participants	9
Mean (Standard Deviation) [Score on scale]	3.9 (1.4)

Adverse Events

Arm/Group Title	Rotigotine
Arm/Group Description	Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
All Cause Mortality
	Rotigotine
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Rotigotine
	Affected / at Risk (%)	# Events
Total	4/14 (28.6%)
Cardiac disorders
Ventricular asystole	1/14 (7.1%)	1
Injury, poisoning and procedural complications
Joint dislocation	1/14 (7.1%)	1
Post procedural haematoma	1/14 (7.1%)	1
Psychiatric disorders
Hallucination	1/14 (7.1%)	1
Other (Not Including Serious) Adverse Events
	Rotigotine
	Affected / at Risk (%)	# Events
Total	10/14 (71.4%)
Blood and lymphatic system disorders
Anaemia	1/14 (7.1%)	1
Ear and labyrinth disorders
Ear Pain	1/14 (7.1%)	1
Gastrointestinal disorders
Constipation	3/14 (21.4%)	5
Nausea	3/14 (21.4%)	3
Diarrhoea	1/14 (7.1%)	1
Abdominal pain upper	1/14 (7.1%)	1
Infections and infestations
Urinary tract infection	3/14 (21.4%)	4
Staphylococcal infection	1/14 (7.1%)	1
Injury, poisoning and procedural complications
Procedural pain	5/14 (35.7%)	5
Investigations
Intraocular pressure increased	1/14 (7.1%)	1
Urine uric acid increased	1/14 (7.1%)	1
Metabolism and nutrition disorders
Iron deficiency	2/14 (14.3%)	2
Hypovolaemia	1/14 (7.1%)	1
Nervous system disorders
Dysaesthesia	1/14 (7.1%)	1
Paraesthesia	1/14 (7.1%)	1
Balance disorder	1/14 (7.1%)	1
Dementia	1/14 (7.1%)	1
Psychiatric disorders
Sleep disorder	2/14 (14.3%)	2
Agitation	1/14 (7.1%)	1
Restlessness	1/14 (7.1%)	1
Psychotic disorder	1/14 (7.1%)	2
Skin and subcutaneous tissue disorders
Pruritus	2/14 (14.3%)	2
Vascular disorders
Hypotension	1/14 (7.1%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.