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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00239486
• Collaborator: (none)
• Enrollment: 109
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 6.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Restless Legs Syndrome	Drug: Pramipexole	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Evaluation of the Effect of Different Doses of Pramipexole on Subjective and Objective Symptoms of Idiopathic Restless Legs Syndrome (RLS).
• Study Start Date: Oct 1, 2002
• Actual Primary Completion Date: Apr 1, 2004
• Study Completion Date: Apr 1, 2004

Outcome Measures

Primary Outcome Measures

1. Reduction in periodic limb movements during time in bed index (PLMI) in the polysomnography (PSG). [3 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NEURO	Helsinki		Finland	FIN-00250

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim Study Coordinator, B.I. Finland Ky

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00239486
• Other Study ID Numbers: 248.515
• First Posted: Oct 17, 2005
• Last Update Posted: Nov 1, 2013
• Last Verified: Oct 1, 2013

• Additional relevant MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome; Pramipexole

Study Results

No Results Posted as of Nov 1, 2013