Dose Finding Study of Pramipexole (Sifrol) in Patients With Idiopathic Restless Legs Syndrome (RLS)
Evaluation of the Effect of Different Doses of Pramipexole on Subjective and Objective Symptoms of Idiopathic Restless Legs Syndrome (RLS).
1 other identifier
interventional
109
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2002
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 14, 2005
CompletedFirst Posted
Study publicly available on registry
October 17, 2005
CompletedNovember 1, 2013
October 1, 2013
1.5 years
October 14, 2005
October 31, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in periodic limb movements during time in bed index (PLMI) in the polysomnography (PSG).
3 weeks
Secondary Outcomes (1)
Secondary outcomes of the study were other PSG-derived endpoints (changes in the RLS symptom rating scale (RLSRS), and patient reported outcomes).
3 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NEURO
Helsinki, FIN-00250, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
B.I. Finland Ky
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 14, 2005
First Posted
October 17, 2005
Study Start
October 1, 2002
Primary Completion
April 1, 2004
Study Completion
April 1, 2004
Last Updated
November 1, 2013
Record last verified: 2013-10