Parkinson DiseaseNCT02231255
Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease
An observational study of Parkinson Disease, run by Boehringer Ingelheim.
Trial summary
Documentation of the effect of an direct or overlapping switch from another dopamine agonist to Sifrol® on motor function, psychopathological disturbances and mood, assessment of the reasons for the switch and the reasons for using Sifrol®, equivalent doses at the end of the switch and tolerability of Sifrol® in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Sifrol®
- How many people
- 1,216 participants
- Where
- No sites listed yet
- Study dates
- Feb 2002to Dec 2002
- 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 Parkinson's disease patients recruited at office-based neurologists, psychiatrist or special neurology clinics
Who may be able to join
- Patients with Idiopathic Parkinson's disease who are planned to undergo a switch from another dopamine agonist to Sifrol®
Who cannot join
- Neurologists and psychiatrists are asked to consider the Summary of Product Characteristics (SPC) for Sifrol®
About this study
Official title: Switch Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease
Documentation of the effect of an direct or overlapping switch from another dopamine agonist to Sifrol® on motor function, psychopathological disturbances and mood, assessment of the reasons for the switch and the reasons for using Sifrol®, equivalent doses at the end of the switch and tolerability of Sifrol® in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions
- Conditions
- Parkinson Disease
- Being tested
- Sifrol®
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sifrol®Drug
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Parkinson's disease patients | Not described Receives: Drug: Sifrol® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reason for switch of therapy and reason for using Sifrol®
questionnaire
Measured: up to 8 weeks
Type of switch (abrupt or overlapping)
Measured: up to 8 weeks
Changes in motor function by means of 5-points rating scale
Short Parkinson's Evaluation Scale (SPES)
Measured: up to 8 weeks
Changes in psychopathological memory disturbances by means of 5- point rating scale
Short Parkinson's Evaluation Scale (SPES)
Measured: up to 8 weeks
Changes in psychopathological thought disorder disturbances by means of 5- point rating scale
SPES score
Measured: up to 8 weeks
Changes in psychopathological depression disturbances by means of 5- point rating scale
SPES score
Measured: up to 8 weeks
Changes of mood on seven visual analogue scales (VASs)
assessed by patient
Measured: up to 8 weeks
Equivalent doses of Sifrol®
compared to previous treatment dosing, based on global clinical impression
Measured: after 8 weeks
Global assessment of efficacy by investigator on a 5-point rating scale
Measured: after 8 weeks
Secondary outcomes (2)
Number of patients with adverse drug reactions
Measured: up to 8 weeks
Assessment of tolerability by investigator on a 5-point rating scale
Measured: after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startFeb 2002
- Primary completionDec 2002
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
- 1,216 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
- NCT02231255
- Sponsor's protocol ID
- 248.517
- Status last verified
- Sep 2014
- First submitted
- 2 Sep 2014
- Last updated
- 17 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switch Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02231255
- Acronym / sponsor ID
- 248.517
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,216 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Primary completion
- Dec 2002 (actual)
- First posted
- 4 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.
Documentation of the effect of an direct or overlapping switch from another dopamine agonist to Sifrol® on motor function, psychopathological disturbances and mood, assessment of the reasons for the switch and the reasons for using Sifrol®, equivalent doses at the end of the switch and tolerability of Sifrol® in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Parkinson's disease patients | – | Drug: Sifrol® |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Idiopathic Parkinson's disease patients recruited at office-based neurologists, psychiatrist or special neurology clinics
Key inclusion criteria (1 listed)
- Patients with Idiopathic Parkinson's disease who are planned to undergo a switch from another dopamine agonist to Sifrol®
Key exclusion criteria (1 listed)
- Neurologists and psychiatrists are asked to consider the Summary of Product Characteristics (SPC) for Sifrol®
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 |
|---|---|---|
| Sifrol® | Drug | Idiopathic Parkinson's disease patients |
Primary outcome
Reason for switch of therapy and reason for using Sifrol®
Time frame: up to 8 weeks
questionnaire
Type of switch (abrupt or overlapping)
Time frame: up to 8 weeks
Changes in motor function by means of 5-points rating scale
Time frame: up to 8 weeks
Short Parkinson's Evaluation Scale (SPES)
Changes in psychopathological memory disturbances by means of 5- point rating scale
Time frame: up to 8 weeks
Short Parkinson's Evaluation Scale (SPES)
Changes in psychopathological thought disorder disturbances by means of 5- point rating scale
Time frame: up to 8 weeks
SPES score
Changes in psychopathological depression disturbances by means of 5- point rating scale
Time frame: up to 8 weeks
SPES score
Changes of mood on seven visual analogue scales (VASs)
Time frame: up to 8 weeks
assessed by patient
Equivalent doses of Sifrol®
Time frame: after 8 weeks
compared to previous treatment dosing, based on global clinical impression
Global assessment of efficacy by investigator on a 5-point rating scale
Time frame: after 8 weeks
2 secondary outcomes
Number of patients with adverse drug reactions
Time frame: up to 8 weeks
Assessment of tolerability by investigator on a 5-point rating scale
Time frame: after 8 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 17 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 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 17 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?
Reason for switch of therapy and reason for using Sifrol® (time frame: up to 8 weeks). The study lists 9 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 17 Sep 2014.