Dose Finding Study of Pramipexole (Sifrol) in Patients With Idiopathic Restless Legs Syndrome (RLS)

Phase 2

Completed

• Conditions: Restless Legs Syndrome

• Registration Number: NCT00239486
• Lead Sponsor: Boehringer Ingelheim

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 determine the optimal dose of pramipexole in patients with RLS by polysomnography and evaluation of clinical improvement.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-14
• Study First Posted: 2005-10-17
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

1. Male and female 18-80 years
2. Confident diagnosis of RLS according to International RLS Study Group criteria
3. RLS rating scale for severity score >15
4. PLM (during time in bed ) index at least 5 per hour
5. Weekly presence of RLS symptoms within last three months
6. Written Informed consent

Exclusion Criteria

1. Women of childbearing potential, who do not use adequate protection such as barrier protection, intrauterine device, or hormonal (oral or subcutaneous) contraception
2. 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
3. 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
4. Any women not having negative serum pregnancy test at screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in periodic limb movements during time in bed index (PLMI) in the polysomnography (PSG).	3 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes of the study were other PSG-derived endpoints (changes in the RLS symptom rating scale (RLSRS), and patient reported outcomes).	3 weeks

Trial Locations

Locations (1)

NEURO; 🇫🇮 Helsinki, Finland