Status:
COMPLETED
Non-interventional Observational Study on the Influence of Pramipexole on Sensory Symptoms of Restless Legs Syndrome (RLS)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18+ years
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 a...
Detailed Description
Study Design:
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diagnosis of primary moderate to severe Restless Legs Syndrome.
- Patients who are planned to be treated with Sifrol® (pramipexole) and where the decision of treatment is made independent of the patients' inclusion into this post marketing surveillance study.
- Male or female patients aged at least 18 years.
- Written informed consent by the patient for study participation.
- Exclusion criteria:
- Any contraindications according to the Summary of Product Characteristics: hypersensitivity to pramipexole or to any of the excipients.
- Previous or ongoing treatment with Sifrol® (pramipexole).
- Previous or ongoing treatment with dopamine receptor agonists.
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
1504 Patients enrolled
Trial Details
Trial ID
NCT00887289
Start Date
April 1 2009
End Date
October 1 2009
Last Update
June 27 2014
Active Locations (784)
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1
Boehringer Ingelheim Investigational Site
Aalen, Germany
2
Boehringer Ingelheim Investigational Site 1
Achim, Germany
3
Boehringer Ingelheim Investigational Site 2
Achim, Germany
4
Boehringer Ingelheim Investigational Site 1
Ahrensburg, Germany