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

Restless Legs Syndrome Clinical Trial

Official title:

Evaluation of the Effect of Different Doses of Pramipexole on Subjective and Objective Symptoms of Idiopathic Restless Legs Syndrome (RLS).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239486
• Other study ID #: 248.515
• Status: Completed
• Phase: Phase 2
• First received: October 14, 2005
• Last updated: October 31, 2013
• Start date: October 2002
• Est. completion date: April 2004

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• Pramipexole

Locations

Country	Name	City	State
Finland	NEURO	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in periodic limb movements during time in bed index (PLMI) in the polysomnography (PSG).		3 weeks
Secondary	Secondary outcomes of the study were other PSG-derived endpoints (changes in the RLS symptom rating scale (RLSRS), and patient reported outcomes).		3 weeks

External Links

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