Non-interventional Observational Study on the Influence of Pramipexole on Sensory Symptoms of Restless Legs Syndrome (RLS)
- Conditions
- Restless Legs Syndrome
- Registration Number
- NCT00887289
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The main goal of this open-label, prospective, non-controlled, non-interventional post marketing surveillance study is to evaluate how pramipexole treatment works when applied in actual practice. In actual practice patients who would have been excluded in the clinical registration studies of pramipexole in moderate to severe primary Restless Legs Syndrome (i.e. those with certain disease histories, co-morbidities and/or demographic characteristics) will also be treated with pramipexole. Thus, during this post marketing surveillance study additional information on the efficacy and safety of pramipexole in those patients will be obtained. The objectives of this post marketing surveillance study are:
* To investigate the influence of Sifrol® (pramipexole) treatment on unpleasant sensory symptoms of Restless Legs Syndrome as measured with the short form of the McGill Pain Questionnaire.
* To assess if improvement of sensory symptoms correlates with overall Restless Legs Syndrome severity (International Restless Legs Syndrome Scale for Severity) and with secondary symptoms like sleeping problems and daytime tiredness (items 1 \& 6 from Restless Legs Syndrome-6).
* To evaluate if the treatment effect of Sifrol on overall Restless Legs Syndrome severity (International Restless Legs Syndrome Scale for Severity) differs between patients with high pain scores and patients with lower pain scores.
* To compare General Practitioner and neurologist sites patient populations in terms of demographics, Restless Legs Syndrome severity at Visit 1 and treatment outcomes at Visit 3.
* To evaluate the development of behavioural changes under pramipexole treatment.
- Detailed Description
Study Design:
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1504
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 Baseline to Visit 3 Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by General Practitioner Baseline to Visit 3 Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by Neurologist Baseline to Visit 3 Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
- Secondary Outcome Measures
Name Time Method Summary of Change From Baseline in Restless Legs Syndrome Severity Scale With 6 Questions to Visit 3 Baseline to Visit 3 Change in RLS-6 at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 20 (worst) A negative change is an improvement of RLS-6, a positive change a worsening of RLS-6.
Summary of Change From Baseline in International Restless Legs Syndrome Scale for Severity to Visit 3 Baseline to Visit 3 Change in IRLS at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 40 (worst) A negative change is an improvement of IRLS, a positive change a worsening of IRLS.
Behavioural Changes During Treatment Baseline to Visit 3 Number of patients with occurence of behavioural changes in terms of impulse control disorders
Trial Locations
- Locations (34)
Boehringer Ingelheim Investigational Site 1
🇩🇪Zwickau, Germany
Boehringer Ingelheim Investigational Site 2
🇩🇪Zwickau, Germany
Boehringer Ingelheim Investigational Site 3
🇩🇪Wuppertal, Germany
Boehringer Ingelheim Investigational Site 10
🇩🇪Stuttgart, Germany
Boehringer Ingelheim Investigational Site 11
🇩🇪Stuttgart, Germany
Boehringer Ingelheim Investigational Site 12
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 14
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 16
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 13
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 17
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 18
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 19
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 20
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 23
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 25
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 27
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 28
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 31
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 4
🇩🇪Wuppertal, Germany
Boehringer Ingelheim Investigational Site 5
🇩🇪Stuttgart, Germany
Boehringer Ingelheim Investigational Site 32
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 33
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 6
🇩🇪Stuttgart, Germany
Boehringer Ingelheim Investigational Site 7
🇩🇪Stuttgart, Germany
Boehringer Ingelheim Investigational Site 8
🇩🇪Stuttgart, Germany
Boehringer Ingelheim Investigational Site 9
🇩🇪Stuttgart, Germany
Boehringer Ingelheim Investigational Site 15
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 26
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site 29
🇩🇪Berlin, Germany
Boehringer Ingelheim Investigational Site
🇩🇪Übach-Palenberg, Germany
Boehringer Ingelheim Investigational Site 24
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 21
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 22
🇩🇪Hamburg, Germany
Boehringer Ingelheim Investigational Site 30
🇩🇪Berlin, Germany