Parkinson DiseaseNCT02231294
The Effect of Sifrol® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease
An observational study of Parkinson Disease, run by Boehringer Ingelheim.
Trial summary
Documentation of the effect of SIFROL® on tremor and depression as well as its tolerability in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions 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
- 1,464 participants
- Where
- No sites listed yet
- Study dates
- Jul 2000to Jan 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: Ambulatory patients with idiopathic parkinson's disease requiring therapy with Sifrol®
Who may be able to join
- Patients with idiopathic Parkinson's disease with tremor and/or depression requiring therapy with Sifrol® or change of therapy to Sifro®l and not under medication with neuroleptics were allowed to be observed during the study
Who cannot join
- Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SPC) for Sifrol®
- Patients under treatment with neuroleptics should not be observed during this study
About this study
Official title: The Effect of SIFROL® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease Patients.
Documentation of the effect of SIFROL® on tremor and depression as well as its tolerability 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.
Change in Parkinson signs and symptoms by means of a 4-point rating scale
Measured: up to 6 weeks
Occurrence of tremor (rest and postural) by means of a 4-point rating scale
Short Parkinson's Evaluation Scale (SPES)
Measured: up to 6 weeks
Change in severity of kinetic tremor assessed by tremor spiral test
Measured: up to 6 weeks
Occurrence of depression by means of a 4-point SPES rating scale
Measured: up to 6 weeks
Change in severity of depression by means of an 8-point rating scale
Clinical Global Impression (CGI) rating scale
Measured: up to 6 weeks
Self-Assessment of depression by patient by means of six different visual analogue scales (VAS)
VAS (10 cm)
Measured: up to 6 weeks
Assessment of efficacy by investigator on a 5-point rating scale
Measured: after 6 weeks
Secondary outcomes (3)
Number of patients with adverse drug reactions
Measured: up to 6 weeks
Assessment of tolerability by investigator on a 5-point scale
Measured: after 6 weeks
Assessment of tolerability by patient on a 5-point scale
Measured: after 6 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 startJul 2000
- Primary completionJan 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
- 1,464 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
- NCT02231294
- Sponsor's protocol ID
- 248.511
- Status last verified
- Sep 2014
- First submitted
- 2 Sep 2014
- Last updated
- 4 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of SIFROL® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease Patients.
- ClinicalTrials.gov ID
- NCT02231294
- Acronym / sponsor ID
- 248.511
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,464 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2000
- Primary completion
- Jan 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 SIFROL® on tremor and depression as well as its tolerability 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
- Ambulatory patients with idiopathic parkinson's disease requiring therapy with Sifrol®
Key inclusion criteria (1 listed)
- Patients with idiopathic Parkinson's disease with tremor and/or depression requiring therapy with Sifrol® or change of therapy to Sifro®l and not under medication with neuroleptics were allowed to be observed during the study
Key exclusion criteria (2 listed)
- Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SPC) for Sifrol®
- Patients under treatment with neuroleptics should not be observed during this study
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
Change in Parkinson signs and symptoms by means of a 4-point rating scale
Time frame: up to 6 weeks
Occurrence of tremor (rest and postural) by means of a 4-point rating scale
Time frame: up to 6 weeks
Short Parkinson's Evaluation Scale (SPES)
Change in severity of kinetic tremor assessed by tremor spiral test
Time frame: up to 6 weeks
Occurrence of depression by means of a 4-point SPES rating scale
Time frame: up to 6 weeks
Change in severity of depression by means of an 8-point rating scale
Time frame: up to 6 weeks
Clinical Global Impression (CGI) rating scale
Self-Assessment of depression by patient by means of six different visual analogue scales (VAS)
Time frame: up to 6 weeks
VAS (10 cm)
Assessment of efficacy by investigator on a 5-point rating scale
Time frame: after 6 weeks
3 secondary outcomes
Number of patients with adverse drug reactions
Time frame: up to 6 weeks
Assessment of tolerability by investigator on a 5-point scale
Time frame: after 6 weeks
Assessment of tolerability by patient on a 5-point scale
Time frame: after 6 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 4 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 2 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 4 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 Parkinson signs and symptoms by means of a 4-point rating scale (time frame: up to 6 weeks). The study lists 7 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 4 Sep 2014.