Idiopathic Parkinson's DiseaseNEUPARTNCT02227355
Evaluating the Effectiveness of Neupro® (Rotigotine) and L-dopa Combination Therapy in Patients With Parkinson's Disease
An observational study of Idiopathic Parkinson's Disease, run by UCB Biopharma S.P.R.L. at 42 sites in 5 countries.
Trial summary
This study aims to evaluate the effectiveness of Rotigotine and Levodopa combination therapy for younger and older patients with Parkinson's Disease under real life conditions. Effects on ability to perform activities of daily living, sleep, medication dose and other factors will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Parkinson's Disease
- How many people
- 195 participants
- Where
- 42 sitesin 5 countries
- Study dates
- Sep 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with idiopathic Parkinson's Disease receiving levodopa as monotherapy or in combination with a dopamine agonist other than Rotigotine, but either not sufficiently controlled on or intolerant to current treatment, or other reason; patients are receiving treatment in general practitioner (GP) offices, private clinics or hospitals (including university hospitals) according to routine daily practice.
Who may be able to join
- The following selection criteria must be followed for patients entering the Noninterventional Study (NIS):
- The decision by the treating physician to prescribe Rotigotine transdermal patch is made before participating in the NIS due to a clinical therapeutic indication (e.g., because of intolerance and/or ineffectiveness of another dopamine agonist)
- The patient is either male or female and over 18 years of age
- A Patient Data Consent form is signed and dated by the patient or by the legal representative
- The patient has idiopathic Parkinson's Disease, has not received Rotigotine within 28 days prior to the Baseline Visit and is willing to participate in questionnaire based assessments
- The patient is receiving L-dopa as monotherapy or a combination therapy composed of L-dopa and a dopamine agonist other than Rotigotine
- The patient has been on L-dopa therapy for at least 6 months and is responding to initial L-dopa therapy
- The patient has a Hoehn and Yahr stage score of 1 to 4.
Who cannot join
- Patients will be excluded from the study if they have participated in a clinical study of a medication or a medical device within 3 months prior to Baseline or if they are participating in a clinical study at the time of inclusion or have already participated in the current study.
Trial locations and contacts
42 sites in 5 countries.
42 sites in 5 countries
Germany15 sites
6
Alzenau in Unterfranken
51
Aschaffenburg
13
Beelitz-Heilstätten
12
Berlin
5
Böblingen
53
Düsseldorf
7
Erbach im Odenwald
4
Haag
11
Leer
2
Münster
54
Schriesheim
8
Senftenberg
14
Tübingen
10
Ulm
3
Westerstede
United Kingdom11 sites
37
Bury
49
Cambridge
52
Lincoln
48
Liverpool
33
London
36
London
34
Manchester
31
Middlesbrough
38
North Shields
35
Norwich
63
Plymouth
Italy9 sites
45
Ancona
47
Brescia
60
Cagliari
29
Cosenza
30
Florence
46
Milan
27
Naples
28
Roma
62
Roma
Spain4 sites
20
Barakaldo
15
Donostia / San Sebastian
24
Madrid
22
Palma de Mallorca
About this study
Official title: A Multi-center Noninterventional Study to Evaluate the Effectiveness of Neupro® (Rotigotine Transdermal Patch) and Levodopa Combination Therapy in Patients With Parkinson's Disease (NEUPART)
This study aims to evaluate the effectiveness of Rotigotine and Levodopa combination therapy for younger and older patients with Parkinson's Disease under real life conditions. Effects on ability to perform activities of daily living, sleep, medication dose and other factors will be assessed.
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Parkinson's Disease, Neupro®, Rotigotine, Transdermal patch, NEUPART, Levodopa, Noninterventional, Combination therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PD Patients < 70 years of age | Patients with Parkinson's Disease (PD) <70 years of age. | |
| PD Patients ≥ 70 years of age | Patients with Parkinson's Disease (PD) ≥ 70 years of age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to end of the Observational Period in Unified Parkinson's Disease Rating Scale Part II (UPDRS Part II) total score
The UPDRS Part II (Activities of Daily Living) consists of 13 items, each to be scored between 0 (normal/none) and 4 (highest level of severity). The sum score is calculated as the sum of the 13 individual scores (13 questions=52 points maximum; the higher the sum score, the greater degree of disability).
Measured: Baseline to end of Observational Period (6 months)
Secondary outcomes (4)
Change from Baseline to end of the Observational Period in L-dopa dose
Measured: Baseline to end of Observational Period (6 months)
Change from Baseline to end of the Observation Period in Parkinson's Disease Sleep Scale (PDSS-2) total score
The PDSS-2 is a 15 item scale that is used to assess sleep and nocturnal disability in Parkinson's Disease. It is designed for interviewer-administered completion or self-completion by patients.
Patients are asked to rate how often during the past week he/she slept well or experienced various symptoms of sleep disability. Each of the 15 items are to be scored between 0 (never) to 4 (very often) with the total score ranging from 0 to 60; the higher the sum score, the greater the degree of impairment.
Measured: Baseline to end of Observational Period (6 months)
Response at the end of the Observation Period defined as 20 % decrease in Unified Parkinson's Disease Rating Scale Part II (UPDRS Part II) total score
The UPDRS Part II (Activities of Daily Living) consists of 13 items, each to be scored between 0 (normal/none) and 4 (highest level of severity). The sum score is calculated as the sum of the 13 individual scores (13 questions = 52 points maximum); the higher the sum score, the greater degree of disability.
Measured: End of the Observation Period (Month 6)
Assessment at the end of the Observation Period in the score of the Clinical Global Impressions (CGI) Item 2 (Global Rating of Change of Condition)
CGI Item 2 (Global Rating of Change of Condition) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. Scores range from 0 to 7 as follows: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.
Measured: End of the Observation Period (Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227355
- Sponsor's protocol ID
- PD0013
- Acronym
- NEUPART
- Status last verified
- Jul 2016
- First submitted
- 26 Aug 2014
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Noninterventional Study to Evaluate the Effectiveness of Neupro® (Rotigotine Transdermal Patch) and Levodopa Combination Therapy in Patients With Parkinson's Disease (NEUPART)
- ClinicalTrials.gov ID
- NCT02227355
- Acronym / sponsor ID
- NEUPART / PD0013
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Parkinson's Disease, Neupro®, Rotigotine, Transdermal patch, NEUPART, Levodopa, Noninterventional, Combination therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness of Rotigotine and Levodopa combination therapy for younger and older patients with Parkinson's Disease under real life conditions. Effects on ability to perform activities of daily living, sleep, medication dose and other factors will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD Patients < 70 years of age | – | –Patients with Parkinson's Disease (PD) <70 years of age. |
| PD Patients ≥ 70 years of age | – | –Patients with Parkinson's Disease (PD) ≥ 70 years of age. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with idiopathic Parkinson's Disease receiving levodopa as monotherapy or in combination with a dopamine agonist other than Rotigotine, but either not sufficiently controlled on or intolerant to current treatment, or other reason; patients are receiving treatment in general practitioner (GP) offices, private clinics or hospitals (including university hospitals) according to routine daily practice.
Key inclusion criteria (8 listed)
- The following selection criteria must be followed for patients entering the Noninterventional Study (NIS):
- The decision by the treating physician to prescribe Rotigotine transdermal patch is made before participating in the NIS due to a clinical therapeutic indication (e.g., because of intolerance and/or ineffectiveness of another dopamine agonist)
- The patient is either male or female and over 18 years of age
- A Patient Data Consent form is signed and dated by the patient or by the legal representative
- The patient has idiopathic Parkinson's Disease, has not received Rotigotine within 28 days prior to the Baseline Visit and is willing to participate in questionnaire based assessments
Key exclusion criteria (1 listed)
- Patients will be excluded from the study if they have participated in a clinical study of a medication or a medical device within 3 months prior to Baseline or if they are participating in a clinical study at the time of inclusion or have already participated in the current study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline to end of the Observational Period in Unified Parkinson's Disease Rating Scale Part II (UPDRS Part II) total score
Time frame: Baseline to end of Observational Period (6 months)
The UPDRS Part II (Activities of Daily Living) consists of 13 items, each to be scored between 0 (normal/none) and 4 (highest level of severity). The sum score is calculated as the sum of the 13 individual scores (13 questions=52 points maximum; the higher the sum score, the greater degree of disability).
4 secondary outcomes
Change from Baseline to end of the Observational Period in L-dopa dose
Time frame: Baseline to end of Observational Period (6 months)
Change from Baseline to end of the Observation Period in Parkinson's Disease Sleep Scale (PDSS-2) total score
Time frame: Baseline to end of Observational Period (6 months)
Response at the end of the Observation Period defined as 20 % decrease in Unified Parkinson's Disease Rating Scale Part II (UPDRS Part II) total score
Time frame: End of the Observation Period (Month 6)
Assessment at the end of the Observation Period in the score of the Clinical Global Impressions (CGI) Item 2 (Global Rating of Change of Condition)
Time frame: End of the Observation Period (Month 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2016.
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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)
42 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Parkinson's Disease, run by UCB Biopharma S.P.R.L. at 42 sites in 5 countries.
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 8 inclusion and 1 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 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Germany, United Kingdom, Italy, Spain, France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline to end of the Observational Period in Unified Parkinson's Disease Rating Scale Part II (UPDRS Part II) total score (time frame: Baseline to end of Observational Period (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jul 2016.