Trial Outcomes & Findings for A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery (NCT NCT00594464)

Last Updated: 2014-10-02

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

After subject wakes up from general anesthesia

Results posted on

2014-10-02

Participant Flow

Participant milestones

Participant milestones
Measure	Rotigotine Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
Overall Study STARTED	14
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Rotigotine Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
Overall Study Withdrawal by Subject	1
Overall Study Delay in operation	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rotigotine n=14 Participants Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	68.7 years STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment Germany	14 participants n=5 Participants

PRIMARY outcome

Timeframe: After subject wakes up from general anesthesia

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

Outcome measures

Outcome measures
Measure	Rotigotine n=9 Participants Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.	Rotigotine 6mg/24h	Rotigotine 8 mg/24h	Rotigotine 12 mg/24h	Rotigotine 14 mg/24h	Rotigotine 16 mg/24h
Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist.	5.0 Score on scale Standard Deviation 1.8	—	—	—	—	—

PRIMARY outcome

Timeframe: 2 weeks after surgery

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

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

Outcome measures

Outcome measures
Measure	Rotigotine n=9 Participants Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.	Rotigotine 6mg/24h	Rotigotine 8 mg/24h	Rotigotine 12 mg/24h	Rotigotine 14 mg/24h	Rotigotine 16 mg/24h
Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Neurologist.	5.2 Score on scale Standard Deviation 2.2	—	—	—	—	—

PRIMARY outcome

Timeframe: 2 weeks after surgery

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

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

Outcome measures

Outcome measures
Measure	Rotigotine n=9 Participants Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.	Rotigotine 6mg/24h	Rotigotine 8 mg/24h	Rotigotine 12 mg/24h	Rotigotine 14 mg/24h	Rotigotine 16 mg/24h
Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Patient.	3.9 Score on scale Standard Deviation 1.4	—	—	—	—	—

SECONDARY outcome

Timeframe: 24 hours

Population: 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)

Outcome measures

Outcome measures
Measure	Rotigotine n=1 Participants Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.	Rotigotine 6mg/24h n=1 Participants	Rotigotine 8 mg/24h n=2 Participants	Rotigotine 12 mg/24h n=2 Participants	Rotigotine 14 mg/24h n=1 Participants	Rotigotine 16 mg/24h n=3 Participants
Plasma Concentration of Rotigotine After Use.	0.1640 ng/ml Standard Deviation 0	0.2480 ng/ml Standard Deviation 0	0.7570 ng/ml Standard Deviation 0.1569	0.8405 ng/ml Standard Deviation 0.3302	0.8689 ng/ml Standard Deviation 0	1.6958 ng/ml Standard Deviation 2.1951

Adverse Events

Rotigotine

Serious events: 4 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rotigotine n=14 participants at risk Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
Cardiac disorders Ventricular asystole	7.1% 1/14 • Number of events 1
Injury, poisoning and procedural complications Joint dislocation	7.1% 1/14 • Number of events 1
Injury, poisoning and procedural complications Post procedural haematoma	7.1% 1/14 • Number of events 1
Psychiatric disorders Hallucination	7.1% 1/14 • Number of events 1

Other adverse events

Other adverse events
Measure	Rotigotine n=14 participants at risk Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
Blood and lymphatic system disorders Anaemia	7.1% 1/14 • Number of events 1
Ear and labyrinth disorders Ear Pain	7.1% 1/14 • Number of events 1
Gastrointestinal disorders Constipation	21.4% 3/14 • Number of events 5
Gastrointestinal disorders Nausea	21.4% 3/14 • Number of events 3
Gastrointestinal disorders Diarrhoea	7.1% 1/14 • Number of events 1
Gastrointestinal disorders Abdominal pain upper	7.1% 1/14 • Number of events 1
Infections and infestations Urinary tract infection	21.4% 3/14 • Number of events 4
Infections and infestations Staphylococcal infection	7.1% 1/14 • Number of events 1
Investigations Intraocular pressure increased	7.1% 1/14 • Number of events 1
Investigations Urine uric acid increased	7.1% 1/14 • Number of events 1
Metabolism and nutrition disorders Iron deficiency	14.3% 2/14 • Number of events 2
Metabolism and nutrition disorders Hypovolaemia	7.1% 1/14 • Number of events 1
Nervous system disorders Dysaesthesia	7.1% 1/14 • Number of events 1
Nervous system disorders Paraesthesia	7.1% 1/14 • Number of events 1
Nervous system disorders Balance disorder	7.1% 1/14 • Number of events 1
Nervous system disorders Dementia	7.1% 1/14 • Number of events 1
Psychiatric disorders Sleep disorder	14.3% 2/14 • Number of events 2
Psychiatric disorders Agitation	7.1% 1/14 • Number of events 1
Psychiatric disorders Restlessness	7.1% 1/14 • Number of events 1
Psychiatric disorders Psychotic disorder	7.1% 1/14 • Number of events 2
Skin and subcutaneous tissue disorders Pruritus	14.3% 2/14 • Number of events 2
Vascular disorders Hypotension	7.1% 1/14 • Number of events 3
Injury, poisoning and procedural complications Procedural pain	35.7% 5/14 • Number of events 5

Additional Information

UCB Clinical Trial Call Center

UCB Pharma

Phone: +1 877 822 9493

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER