Restless Legs SyndromeNCT02248155
Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)
An observational study of Restless Legs Syndrome, run by Boehringer Ingelheim.
Trial summary
The objectives of this Post Marketing Surveillance (PMS) are: Evaluation of the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Syndrome Scale (IRLS) and Clinical Global Impression Improvement scale (CGI- I) Evaluation of the time to reaching… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Pramipexole
- How many people
- 2,644 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Nov 2006
- 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 suffering from moderate to severe RLS recruited at office-based general practitioners and interists
Who may be able to join
- Patients suffering from primary RLS who are eligible for Pramipexol (PPX) treatment could be included into the study
- Patients not pre-treated with any dopaminergic agent (de novo patients) or patients pre-treated with dopaminergic medication
- Male of female patients of any age
Who cannot join
- The treating physicians are asked to consider the regulations described in the Summary of Product Characteristics (SmPC) for the treatment with pramipexole
About this study
Official title: Sifrol® Onset of Action and Impact on RLS: A 12-week Observational Study in Patients With Primary RLS
The objectives of this Post Marketing Surveillance (PMS) are:
- Evaluation of the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Syndrome Scale (IRLS) and Clinical Global Impression Improvement scale (CGI- I)
- Evaluation of the time to reaching maintenance dose of pramipexole
- Evaluation of work productivity impairment associated with RLS based on the Work Productivity and Activity Impairment Questionnaire (WPAI) questionnaire
- Conditions
- Restless Legs Syndrome
- Being tested
- Pramipexole
- Medical subject headings
- Restless Legs Syndrome
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 |
|---|---|---|
| RLS 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 RLS symptoms (IRLS) on a 4-point rating scale
Measured: up to 12 weeks
Change from Baseline in WPAI by means of a patient questionnaire
Measured: Baseline, 12 weeks
Secondary outcomes (4)
Number of patients with adverse drug reactions
Measured: up to 12 weeks
Global assessment of efficacy by investigator on a 5-point scale
Measured: after 12 weeks
Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale
Measured: up to 12 weeks
Time to reach pramipexol maintenance dose
Measured: up to 12 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 startApr 2006
- Primary completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies 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
- 2,644 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
- NCT02248155
- Sponsor's protocol ID
- 248.618
- 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
- Sifrol® Onset of Action and Impact on RLS: A 12-week Observational Study in Patients With Primary RLS
- ClinicalTrials.gov ID
- NCT02248155
- Acronym / sponsor ID
- 248.618
- Conditions
- Restless Legs Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,644 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Nov 2006 (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 Post Marketing Surveillance (PMS) are:
- Evaluation of the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Syndrome Scale (IRLS) and Clinical Global Impression Improvement scale (CGI- I)
- Evaluation of the time to reaching maintenance dose of pramipexole
- Evaluation of work productivity impairment associated with RLS based on the Work Productivity and Activity Impairment Questionnaire (WPAI) questionnaire
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RLS patients | – | Drug: Pramipexole |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suffering from moderate to severe RLS recruited at office-based general practitioners and interists
Key inclusion criteria (3 listed)
- Patients suffering from primary RLS who are eligible for Pramipexol (PPX) treatment could be included into the study
- Patients not pre-treated with any dopaminergic agent (de novo patients) or patients pre-treated with dopaminergic medication
- Male of female patients of any age
Key exclusion criteria (1 listed)
- The treating physicians are asked to consider the regulations described in the Summary of Product Characteristics (SmPC) for the treatment with pramipexole
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 | RLS patients |
Primary outcome
Assessment of RLS symptoms (IRLS) on a 4-point rating scale
Time frame: up to 12 weeks
Change from Baseline in WPAI by means of a patient questionnaire
Time frame: Baseline, 12 weeks
4 secondary outcomes
Number of patients with adverse drug reactions
Time frame: up to 12 weeks
Global assessment of efficacy by investigator on a 5-point scale
Time frame: after 12 weeks
Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale
Time frame: up to 12 weeks
Time to reach pramipexol maintenance dose
Time frame: up to 12 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 Restless Legs Syndrome, 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 3 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?
Assessment of RLS symptoms (IRLS) on a 4-point rating scale (time frame: up to 12 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.