Parkinson's DiseasePhase 4NEUPOSNCT00594464
A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery
A Phase 4 study testing Rotigotine in people with Parkinson's Disease, run by UCB Pharma at 12 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Rotigotine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 12 sitesGermany
- Study dates
- Sep 2007to May 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Study site
Augsburg
Study site
Bochum
Study site
Bonn
Study site
Bremerhaven
Study site
Dortmund
Study site
Dresden
Study site
Hanau
Study site
Ingolstadt
Study site
Kiel
Study site
Schwerin
Study site
Stralsund
Study site
Ulm
About this study
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
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
- Being tested
- Rotigotine
- Keywords
- Rotigotine, NEUPRO®, Parkinson's Disease (PD), perioperative use, anaesthesia,
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RotigotineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rotigotine Receives: Drug: Rotigotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 2 weeks after surgery
Secondary outcomes (1)
Plasma Concentration of Rotigotine After Use.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594464
- Sponsor's protocol ID
- SP0882
- Other IDs
- 2006-005438-19
- Acronym
- NEUPOS
- Status last verified
- Dec 2010
- First submitted
- 21 Dec 2007
- Last updated
- 2 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20535621
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00594464
- Acronym / sponsor ID
- NEUPOS / SP0882
- Conditions
- Parkinson's Disease
- Keywords
- Rotigotine, NEUPRO®, Parkinson's Disease (PD), perioperative use, anaesthesia,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Posted 3 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of efficacy and safety on the use of rotigotine in patients suffering from Parkinson's Disease during and after surgery requiring general anaesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RotigotineRotigotine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotigotine2 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. | Drug | 1 |
Primary outcome
Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist.
Time frame: 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
Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Neurologist.
Time frame: 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
Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Patient.
Time frame: 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
1 secondary outcome
Plasma Concentration of Rotigotine After Use.
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20535621Wullner 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.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Product InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rotigotine in people with Parkinson's Disease, run by UCB Pharma at 12 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist. (time frame: After subject wakes up from general anesthesia). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00594464, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2014.