Status:
COMPLETED
Dose Finding Study of Pramipexole (Sifrol) in Patients With Idiopathic Restless Legs Syndrome (RLS)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study was to evaluate the efficacy and safety of different doses of pramipexole (Sifrol) on subjective and objective symptoms of idiopathic Restless Legs Syndrome (RLS) and also to...
Eligibility Criteria
Inclusion
- Male and female 18-80 years
- Confident diagnosis of RLS according to International RLS Study Group criteria
- RLS rating scale for severity score \>15
- PLM (during time in bed ) index at least 5 per hour
- Weekly presence of RLS symptoms within last three months
- Written Informed consent
Exclusion
- Women of childbearing potential, who do not use adequate protection such as barrier protection, intrauterine device, or hormonal (oral or subcutaneous) contraception
- Postmenopausal women less than 6 months after last menses, surgically sterilised, oophorectomised or hysterectomised less than 3 months after operation and not using adequate protection
- Women neither using adequate protection nor being postmenopausal and their partner is not sterilised at least 6 months post operation or does not use condom
- Any women not having negative serum pregnancy test at screening
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2004
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00239486
Start Date
October 1 2002
End Date
April 1 2004
Last Update
November 1 2013
Active Locations (1)
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1
NEURO
Helsinki, Finland, FIN-00250