Parkinson DiseaseNCT02236728
Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole
An observational study of Parkinson Disease, run by Boehringer Ingelheim.
Trial summary
The primary objective of this study was to describe neurologists' population of patients treated with pramipexole and suffering from Parkinson's disease (so called 'primary care' population). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Pramipexole
- How many people
- 497 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Nov 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: neurologists' population of patients treated with pramipexole and suffering from Parkinson's disease (so called 'primary care' population)
Who may be able to join
- Patients suffering from idiopathic Parkinson's Disease and treated with pramipexole for at least two months, examined in consultation
Who cannot join
- Patient refusing to take part
- Patient taking part in a clinical trial
About this study
Official title: Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole by Neurologists in France (ETAP)
The primary objective of this study was to describe neurologists' population of patients treated with pramipexole and suffering from Parkinson's disease (so called 'primary care' population).
The secondary objectives were:
- Evaluate the mean dose of pramipexole prescribed under actual conditions of use depending on the severity of the disease.
- Evaluate the reasons for choosing pramipexole as treatment.
- Identify the patient profiles determining the choice of dose of pramipexole prescribed
- Conditions
- Parkinson Disease
- Being tested
- Pramipexole
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PramipexoleDrug
Also called (Sifrol®)
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patients | Not described Receives: Drug: Pramipexole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Patient's demographic characteristics
Measured: 9 months
Assessment of Parkinson's disease characteristics
Measured: 9 months
Secondary outcomes (7)
Assessment of Severity of the Parkinson Disease (PD)
(levels of severity of the disease were defined with the scientific committee in 5 stages: treatment initiation phase, honeymoon phase, therapeutic insufficiency phase, start of motor complications phase and advanced motor complications phase)
Measured: 9 months
Assessment of Disease Stage Stage according to Hoehn and Yahr and Unified Parkinson Disease Rating Scale III (UPDRS III) scores
Measured: 9 months
Description of the actual treatments of PD
Measured: 9 months
Evaluation for reasons for choosing pramipexole as treatment
Measured: 9 months
Assessment of Treatment history
3 subgroups: Initiation: no antiparkinson treatment before the implementation of pramipexole Switch: at least one dopamine agonist replaced by pramipexole Add on: pramipexole is implemented in addition to the previous treatment
Measured: 9 months
Evaluation of the state of health perceived by the patient using the questionnaire EQ-5D
Measured: 9 months
Number of patients with adverse events
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startFeb 2008
- Primary completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236728
- Sponsor's protocol ID
- 248.648
- Status last verified
- Sep 2014
- First submitted
- 10 Sep 2014
- Last updated
- 11 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole by Neurologists in France (ETAP)
- ClinicalTrials.gov ID
- NCT02236728
- Acronym / sponsor ID
- 248.648
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Nov 2008 (actual)
- First posted
- 11 Sep 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.
The primary objective of this study was to describe neurologists' population of patients treated with pramipexole and suffering from Parkinson's disease (so called 'primary care' population).
The secondary objectives were:
- Evaluate the mean dose of pramipexole prescribed under actual conditions of use depending on the severity of the disease.
- Evaluate the reasons for choosing pramipexole as treatment.
- Identify the patient profiles determining the choice of dose of pramipexole prescribed
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients | – | Drug: Pramipexole |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- neurologists' population of patients treated with pramipexole and suffering from Parkinson's disease (so called 'primary care' population)
Key inclusion criteria (1 listed)
- Patients suffering from idiopathic Parkinson's Disease and treated with pramipexole for at least two months, examined in consultation
Key exclusion criteria (2 listed)
- Patient refusing to take part
- Patient taking part in a clinical 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 |
|---|---|---|
| PramipexoleAlso: (Sifrol®) | Drug | Parkinson's disease patients |
Primary outcome
Assessment of Patient's demographic characteristics
Time frame: 9 months
Assessment of Parkinson's disease characteristics
Time frame: 9 months
7 secondary outcomes
Assessment of Severity of the Parkinson Disease (PD)
Time frame: 9 months
Assessment of Disease Stage Stage according to Hoehn and Yahr and Unified Parkinson Disease Rating Scale III (UPDRS III) scores
Time frame: 9 months
Description of the actual treatments of PD
Time frame: 9 months
Evaluation for reasons for choosing pramipexole as treatment
Time frame: 9 months
Assessment of Treatment history
Time frame: 9 months
Evaluation of the state of health perceived by the patient using the questionnaire EQ-5D
Time frame: 9 months
Number of patients with adverse events
Time frame: 9 months
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 11 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Boehringer Ingelheim.
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 1 inclusion and 2 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 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Assessment of Patient's demographic characteristics (time frame: 9 months). The study lists 2 primary outcomes in all. 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 11 Sep 2014.