Parkinson DiseaseNCT02248220
Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease
An observational study of Parkinson Disease, run by Boehringer Ingelheim.
Trial summary
Assessment of daily maintenance dose of Sifrol®, L-dopa sparing effect, effect on tremor, depression, anhedonia and tolerability 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
- 657 participants
- Where
- No sites listed yet
- Study dates
- Oct 1998to Oct 1999
- 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 advanced idiopathic Parkinson's diease recruited at specialist practices and hospitals
Who may be able to join
- Patients with advanced idiopathic Parkinson's disease for whom combined treatment with Sifrol and L-dopa was indicated
Who cannot join
- NA
About this study
Official title: Observation of the Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease
Assessment of daily maintenance dose of Sifrol®, L-dopa sparing effect, effect on tremor, depression, anhedonia and tolerability
- 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.
Change in cumulative daily doses of Sifrol®
Changes in the doses between visits are evaluated using Wilcoxon's signed rank test
Measured: up to 8 weeks
Changes in cumulative daily doses of L-dopa
Changes in the doses between visits are evaluated using Wilcoxon's signed rank test
Measured: up to 8 weeks
Secondary outcomes (9)
Change from Baseline in Short Parkinson Evaluation Scale (SPES) total score
Measured: Baseline, after 8 weeks
Change from Baseline in SPES subscales
Psychopathological disturbances, Activities of daily living, Evaluation of motor function, Tremor, Resting Tremor, Postural tremor, Complications of therapy
Measured: Baseline, after 8 weeks
Change from Baseline in Snaith-Hamilton-Pleasure-Scale total score
patients with SPES depression >= 2
Measured: Baseline, after 8 weeks
Change from Baseline in Tremor Impact Scale (TIS-D) total score
Measured: Baseline, after 8 weeks
Change from Baseline in global Parkinson's Disease (PD) symptoms
Akinesia, anhedonia, depression, dyskinesia, motor fluctuation, cognitive disturbances, rigor and tremor
Measured: Baseline, after 8 weeks
Global assessment of efficacy by investigator on a 5-point scale
Measured: after 8 weeks
Global assessment of tolerability by investigator on a 5-point scale
Measured: after 8 weeks
Number of patients with adverse events
Measured: up to 8 weeks
Number of patients with adverse drug reactions
Measured: up to 8 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 startOct 1998
- Primary completionOct 1999
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
- 657 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
- NCT02248220
- Sponsor's protocol ID
- 248.360
- 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
- Observation of the Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02248220
- Acronym / sponsor ID
- 248.360
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 657 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 1998
- Primary completion
- Oct 1999 (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.
Assessment of daily maintenance dose of Sifrol®, L-dopa sparing effect, effect on tremor, depression, anhedonia and tolerability
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
- Patients with advanced idiopathic Parkinson's diease recruited at specialist practices and hospitals
Key inclusion criteria (1 listed)
- Patients with advanced idiopathic Parkinson's disease for whom combined treatment with Sifrol and L-dopa was indicated
Key exclusion criteria (1 listed)
- NA
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
Change in cumulative daily doses of Sifrol®
Time frame: up to 8 weeks
Changes in the doses between visits are evaluated using Wilcoxon's signed rank test
Changes in cumulative daily doses of L-dopa
Time frame: up to 8 weeks
Changes in the doses between visits are evaluated using Wilcoxon's signed rank test
9 secondary outcomes
Change from Baseline in Short Parkinson Evaluation Scale (SPES) total score
Time frame: Baseline, after 8 weeks
Change from Baseline in SPES subscales
Time frame: Baseline, after 8 weeks
Change from Baseline in Snaith-Hamilton-Pleasure-Scale total score
Time frame: Baseline, after 8 weeks
Change from Baseline in Tremor Impact Scale (TIS-D) total score
Time frame: Baseline, after 8 weeks
Change from Baseline in global Parkinson's Disease (PD) symptoms
Time frame: Baseline, after 8 weeks
Global assessment of efficacy by investigator on a 5-point scale
Time frame: after 8 weeks
Global assessment of tolerability by investigator on a 5-point scale
Time frame: after 8 weeks
Number of patients with adverse events
Time frame: up to 8 weeks
Number of patients with adverse drug reactions
Time frame: up to 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 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 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 cumulative daily doses of Sifrol® (time frame: up to 8 weeks). 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.