Parkinson DiseaseNCT02248168
Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease
An observational study of Parkinson Disease, run by Boehringer Ingelheim.
Trial summary
The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as shown below through the Post Marketing Surveillance (PMS) study upon approval. Unexpected adverse events (especially, serious adverse events (SAEs)) To find out the status of incidence of adverse events under actual practice… 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
- 1,449 participants
- Where
- No sites listed yet
- Study dates
- Mar 2002to Jan 2007
- 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: Patients with idiopathic Parkinson's disease
Who may be able to join
- Among the patients with idiopathic Parkinson's disease, from those receiving MIRAPEX Tablets first after a contract of the study to the requested number of cases will be consecutively enrolled without skipping
Who cannot join
- Following patients are contraindicated.
- Patients who are hypersensitive to MIRAPEX or its ingredients
- Refer to the insert paper for other contraindication.
- Following patients should be carefully administered.
- Patient with renal impairment
- Refer to the insert paper for other precaution.
About this study
Official title: Mirapex PMS Study Final Report
The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as shown below through the Post Marketing Surveillance (PMS) study upon approval.
- Unexpected adverse events (especially, serious adverse events (SAEs))
- To find out the status of incidence of adverse events under actual practice
- Factors on the safety profile
- Factors on the efficacy profile
- 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 Mirapex®
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic 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 Unified Parkinson's disease Rating Scale (UPDRS)
Tremor at rest, Rigidity, Body bradykinesia and hypokinesia
Measured: up to 4 weeks
Secondary outcomes (2)
Number of patients with adverse events
Measured: up to 4 weeks
Global Assessment of efficacy by investigator on 3-point scale
Measured: after 4 weeks
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 startMar 2002
- Primary completionJan 2007
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
- 1,449 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
- NCT02248168
- Sponsor's protocol ID
- 248.599
- 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
- Mirapex PMS Study Final Report
- ClinicalTrials.gov ID
- NCT02248168
- Acronym / sponsor ID
- 248.599
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,449 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Jan 2007 (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.
The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as shown below through the Post Marketing Surveillance (PMS) study upon approval.
- Unexpected adverse events (especially, serious adverse events (SAEs))
- To find out the status of incidence of adverse events under actual practice
- Factors on the safety profile
- Factors on the efficacy profile
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Parkinson's disease patients | – | Drug: Pramipexole |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with idiopathic Parkinson's disease
Key inclusion criteria (1 listed)
- Among the patients with idiopathic Parkinson's disease, from those receiving MIRAPEX Tablets first after a contract of the study to the requested number of cases will be consecutively enrolled without skipping
Key exclusion criteria (6 listed)
- Following patients are contraindicated.
- Following patients should be carefully administered.
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: Mirapex® | Drug | Idiopathic Parkinson's disease patients |
Primary outcome
Assessment of Unified Parkinson's disease Rating Scale (UPDRS)
Time frame: up to 4 weeks
Tremor at rest, Rigidity, Body bradykinesia and hypokinesia
2 secondary outcomes
Number of patients with adverse events
Time frame: up to 4 weeks
Global Assessment of efficacy by investigator on 3-point scale
Time frame: after 4 weeks
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 1 inclusion and 6 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?
Assessment of Unified Parkinson's disease Rating Scale (UPDRS) (time frame: up to 4 weeks). 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.