Parkinson's DiseasePIR-001/KNCT00725478
SEDPARK1: Safety and Efficacy Study With the Non-ergot Dopamine-agonist Piribedil in Parkinson's Disease
An observational study of Parkinson's Disease, run by Desitin Arzneimittel GmbH.
Trial summary
The aim of the non-interventional Post Marketing Study is to investigate the use of the non-ergot dopamine agonist piribedil (trade name: CLARIUM) in mono- and combination therapy in patients with Morbus Parkinson. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Piribedil
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Morbus Parkinson who require therapy with dopamine agonists.
Who may be able to join
- Male and female patients 18 years and older.
- Indication: Morbus Parkinson.
- Treatment with piribedil for the first time.
- Monotherapy with piribedil.
- Combination therapy with L-Dopa (from the beginning or secondary) and/or in combination with other antiparkinsonian drugs.
Who cannot join
None listed.
About this study
Official title: Stabilization on, or Change-over to the Non-ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Parkinson Clinic Ambulances and Larger Private Practices.
The aim of the non-interventional Post Marketing Study is to investigate the use of the non-ergot dopamine agonist piribedil (trade name: CLARIUM) in mono- and combination therapy in patients with Morbus Parkinson. Tolerability and course of the disease or change of parkinsonian symptoms during stabilisation on, or change over from other dopamine agonists will be documented under routine conditions. Piribedil should be prescribed according to its marketing authorisation by the responsible neurologist.
- Conditions
- Parkinson's Disease
- Being tested
- Piribedil
- Keywords
- Piribedil (trade name: CLARIUM), non-ergot dopamine agonist, Morbus Parkinson, Tolerability, Efficacy, Post Marketing Surveillance
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiribedilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
to monitor use in real practice including adverse events on piribedil
Measured: 3 months
Secondary outcomes (1)
Efficacy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Desitin Arzneimittel GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725478
- Sponsor's protocol ID
- PIR-001/K
- Acronym
- PIR-001/K
- Status last verified
- Jul 2008
- First submitted
- 28 Jul 2008
- Last updated
- 31 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Castro-Caldas A, Delwaide P, Jost W, Merello M, Williams A, Lamberti P, Aguilar M, Del Signore S, Cesaro P; Parkinson-Control Study Group. The Parkinson-Control study: a 1-year randomized, double-blind trial comparing piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease. Mov Disord. 2006 Apr;21(4):500-9. doi: 10.1002/mds.20750.
PubMed 16267842Rascol O, Dubois B, Caldas AC, Senn S, Del Signore S, Lees A; Parkinson REGAIN Study Group. Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study. Mov Disord. 2006 Dec;21(12):2110-5. doi: 10.1002/mds.21122.
PubMed 17013922Rascol O, Pathak A, Bagheri H, Montastruc JL. Dopaminagonists and fibrotic valvular heart disease: further considerations. Mov Disord. 2004 Dec;19(12):1524-5. doi: 10.1002/mds.20328. No abstract available.
PubMed 15515031
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stabilization on, or Change-over to the Non-ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Parkinson Clinic Ambulances and Larger Private Practices.
- ClinicalTrials.gov ID
- NCT00725478
- Acronym / sponsor ID
- PIR-001/K / PIR-001/K
- Conditions
- Parkinson's Disease
- Keywords
- Piribedil (trade name: CLARIUM), non-ergot dopamine agonist, Morbus Parkinson, Tolerability, Efficacy, Post Marketing Surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Desitin Arzneimittel GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 30 Jul 2008 (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 aim of the non-interventional Post Marketing Study is to investigate the use of the non-ergot dopamine agonist piribedil (trade name: CLARIUM) in mono- and combination therapy in patients with Morbus Parkinson. Tolerability and course of the disease or change of parkinsonian symptoms during stabilisation on, or change over from other dopamine agonists will be documented under routine conditions. Piribedil should be prescribed according to its marketing authorisation by the responsible neurologist.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Morbus Parkinson who require therapy with dopamine agonists.
Key inclusion criteria (5 listed)
- Male and female patients 18 years and older.
- Indication: Morbus Parkinson.
- Treatment with piribedil for the first time.
- Monotherapy with piribedil.
- Combination therapy with L-Dopa (from the beginning or secondary) and/or in combination with other antiparkinsonian drugs.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Piribedil | Drug | – |
Primary outcome
to monitor use in real practice including adverse events on piribedil
Time frame: 3 months
1 secondary outcome
Efficacy
Time frame: 3 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 31 Mar 2010.
- Background: PubMed 16267842Castro-Caldas A, Delwaide P, Jost W, Merello M, Williams A, Lamberti P, Aguilar M, Del Signore S, Cesaro P; Parkinson-Control Study Group. The Parkinson-Control study: a 1-year randomized, double-blind trial comparing piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease. Mov Disord. 2006 Apr;21(4):500-9. doi: 10.1002/mds.20750.
- Background: PubMed 17013922Rascol O, Dubois B, Caldas AC, Senn S, Del Signore S, Lees A; Parkinson REGAIN Study Group. Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study. Mov Disord. 2006 Dec;21(12):2110-5. doi: 10.1002/mds.21122.
- Background: PubMed 15515031Rascol O, Pathak A, Bagheri H, Montastruc JL. Dopaminagonists and fibrotic valvular heart disease: further considerations. Mov Disord. 2004 Dec;19(12):1524-5. doi: 10.1002/mds.20328. No abstract available.
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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's Disease, run by Desitin Arzneimittel GmbH.
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 5 inclusion and 0 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 31 Mar 2010. 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?
to monitor use in real practice including adverse events on piribedil (time frame: 3 months). 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 NCT00725478, which also lists 3 linked publications.
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 31 Mar 2010.