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

This study has been completed.
Information provided by:
Boehringer Ingelheim Identifier:
First received: October 14, 2005
Last updated: October 31, 2013
Last verified: October 2013
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 Intervention Phase
Restless Legs Syndrome Drug: Pramipexole Phase 2

Study Type: Interventional
Study Design: 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).

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Reduction in periodic limb movements during time in bed index (PLMI) in the polysomnography (PSG). [ Time Frame: 3 weeks ]

Secondary Outcome Measures:
  • Secondary outcomes of the study were other PSG-derived endpoints (changes in the RLS symptom rating scale (RLSRS), and patient reported outcomes). [ Time Frame: 3 weeks ]

Estimated Enrollment: 109
Study Start Date: October 2002
Estimated Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00239486

Helsinki, Finland, FIN-00250
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Finland Ky
  More Information Identifier: NCT00239486     History of Changes
Other Study ID Numbers: 248.515
Study First Received: October 14, 2005
Last Updated: October 31, 2013

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents processed this record on September 20, 2017