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Completed

NCT Number: NCT00239486

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

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.

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Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NEURO

Helsinki, FIN-00250, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Pramipexole

Drug

Primary outcomes

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

    Time frame: 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).

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Oct 17, 2005
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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