Parkinson DiseaseNCT02248181
Post Marketing Surveillance Study of Sifrol® in Patients With Idiopathic Parkinson's Disease
An observational study of Parkinson Disease, run by Boehringer Ingelheim.
Trial summary
Study to document pramipexole dosing during monotherapy, occurrence of fluctuations and dyskinesias, dose increases after deterioration of Parkinson's disease (PD) symptoms, assessment of the reasons for add-on treatment with L-Dopa and dosing of pramipexole and L-Dopa when given concomitantly. 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
- 442 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Dec 2005
- 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: Idiopathic PD patients recruited at office-based neurologists, psychiatrists or physicians in special neurological clinics
Who may be able to join
- Diagnosis of early stage idiopathic Parkinson's Disease
- No pre-treatment with any dopaminergic treatment (de novo patients), or Pre-treatment with L-Dopa at doses of < 200 mg/d
Who cannot join
- Treating physicians are asked to consider the regulation described in the Summary of Product Characteristics (SmPC) for the treatment with pramipexole
About this study
Official title: Post Marketing Surveillance Study of Sifrol® - Monotherapy in Patients With Idiopathic Parkinson's Disease
Study to document pramipexole dosing during monotherapy, occurrence of fluctuations and dyskinesias, dose increases after deterioration of Parkinson's disease (PD) symptoms, assessment of the reasons for add-on treatment with L-Dopa and dosing of pramipexole and L-Dopa when given concomitantly.
- 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 |
|---|---|---|
| Idiopathic PD patients | Not described Receives: Drug: Pramipexole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dosing details of Pramipexole
Measured: up to 21 months
Occurrence and clinical course of Parkinson Disease (PD) motor symptoms
Measured: up to 21 months
Secondary outcomes (5)
Assessment of Kinetic Tremor
Spiral test with at least five rotations from the centre to the edge in blinded fashion
Measured: up to 21 months
Change in dosing details of L-Dopa
Measured: up to 21 months
Global Assessment of tolerability by investigator on 4-point scale
Measured: after 21 months
Global assessment of efficacy by investigator on a 4-point scale
Measured: after 21 months
Number of patients with adverse drug reactions
Measured: up to 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startFeb 2004
- Primary completionDec 2005
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
- 442 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
- NCT02248181
- Sponsor's protocol ID
- 248.539
- Status last verified
- Sep 2014
- First submitted
- 22 Sep 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance Study of Sifrol® - Monotherapy in Patients With Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02248181
- Acronym / sponsor ID
- 248.539
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Dec 2005 (actual)
- First posted
- 25 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.
Study to document pramipexole dosing during monotherapy, occurrence of fluctuations and dyskinesias, dose increases after deterioration of Parkinson's disease (PD) symptoms, assessment of the reasons for add-on treatment with L-Dopa and dosing of pramipexole and L-Dopa when given concomitantly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idiopathic PD patients | – | Drug: Pramipexole |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Idiopathic PD patients recruited at office-based neurologists, psychiatrists or physicians in special neurological clinics
Key inclusion criteria (2 listed)
- Diagnosis of early stage idiopathic Parkinson's Disease
- No pre-treatment with any dopaminergic treatment (de novo patients), or Pre-treatment with L-Dopa at doses of < 200 mg/d
Key exclusion criteria (1 listed)
- Treating physicians are asked to consider the regulation described in the Summary of Product Characteristics (SmPC) for the treatment with pramipexole
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 | Idiopathic PD patients |
Primary outcome
Change in dosing details of Pramipexole
Time frame: up to 21 months
Occurrence and clinical course of Parkinson Disease (PD) motor symptoms
Time frame: up to 21 months
5 secondary outcomes
Assessment of Kinetic Tremor
Time frame: up to 21 months
Change in dosing details of L-Dopa
Time frame: up to 21 months
Global Assessment of tolerability by investigator on 4-point scale
Time frame: after 21 months
Global assessment of efficacy by investigator on a 4-point scale
Time frame: after 21 months
Number of patients with adverse drug reactions
Time frame: up to 21 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 25 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 2 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 25 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?
Change in dosing details of Pramipexole (time frame: up to 21 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 25 Sep 2014.