A Phase IV Trial With Pramipexole to Investigate the Effects on RLS Symptoms and Sleep Disturbance in Patients With RLS

This study has been completed.
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
First received: July 6, 2006
Last updated: May 18, 2012
Last verified: May 2012
The primary objective of this study is to investigate the effects on RLS symptoms and sleep disturbance of pramipexole (Mirapexin) 0.125 mg/day to 0.75 mg/day per os for 12 weeks, compared to placebo, in the treatment of patients with idiopathic Restless Legs Syndrome

Condition Intervention Phase
Restless Legs Syndrome
Drug: Pramipexole
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With Pramipexole (Sifrol®, Mirapexin®) 0.125-0.75 mg/Day Per os for 12 Weeks to Investigate the Effects on RLS Symptoms (IRLS) and Sleep Disturbance (MOS Sleep Scale) in Out-patients With Idiopathic Restless Legs Syndrome

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Primary endpoint: change from baseline after 12 weeks in IRLS total score. Co-primary endpoint: change from baseline after 12 weeks in MOS sleep disturbance score. [ Time Frame: 12 weeks after start of treatment ]

Secondary Outcome Measures:
  • Secondary endpoints: CGI-I and IRLS responder rate other MOS dimensions, RLS-6 items 4-6, IRLS item 10, VAS ,Verbal Fluency Tests ,RLS-QoL scores PGI responder rate adverse event profile, systolic and diastolic blood pressure, pulse rate [ Time Frame: 12 weeks after start of treatment ]

Enrollment: 369
Study Start Date: July 2006
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Written informed consent consistent with ICH-GCP and local IRB/IEC requirements obtained prior to any study procedures being performed and the ability and willingness to comply with study treatment regimen and to attend study assessments.
  2. Male or female out-patients aged 18-80 years.
  3. Diagnosis of idiopathic RLS according to the clinical RLS criteria of the IRLSSG [P03-03355]. All four criteria must be present to fulfil the diagnosis of RLS:

    • An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. (Sometimes the urge to move is present without the uncomfortable sensations and sometimes the arms or other body parts are involved in addition to the legs)
    • The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting
    • The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues
    • The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. (When symptoms are very severe, the worsening at night may not be noticeable but must have been previously present).
  4. RLS symptoms present at least 2 to 3 days per week during the last 3 months prior to baseline (Visit 2).
  5. IRLS total score >15 at baseline (Visit 2).

Exclusion Criteria:

  1. Women of child-bearing potential who do not use during the trial an adequate method of contraception.
  2. Women of child-bearing potential not having negative pregnancy test at screening.
  3. Breastfeeding women.
  4. Concomitant or previous pharmacologic therapy for RLS with: dopamine agonists or levodopa (within 14 days prior to baseline), levodopa with augmentation, unsuccessful prior treatment with non-ergot dopamine agonists.
  5. All treatment less than 14 days or concomitant treatment with medication or dietary supplements which could significantly influence RLS symptoms.
  6. Withdrawal symptoms.
  7. Pramipexole non-responders in other indications than RLS.
  8. Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets.
  9. Diabetes mellitus requiring insulin therapy.
  10. Any of the following laboratory results at screening:

    • any clinically significant abnormalities in laboratory parameters;
    • haemoglobin below LLN.
  11. Clinically significant renal disease or calculated creatinine clearance lower than 30 mL/minute.
  12. Clinically significant hepatic disease or GPT >2 times the ULN.
  13. Serum ferritin <10 ng/mL.
  14. History of/or malignant melanoma.
  15. History of/or clinically significant vision abnormalities.
  16. History of/or any other sleep disorder (other than RLS-related).
  17. History of/or major depressive disorder or any psychotic disorder, mental disorders or any present Axis I psychiatric disorder according to DSM IV requiring any medical therapy.
  18. History of/or clinical signs of suicidal behaviour, suicide ideation or acute suicidal tendency according to the investigator's opinion.
  19. History of/or alcohol abuse or drug addiction (within 2 years).
  20. Patients on a shift-work-schedule or who are otherwise unable to follow a regular sleep-wake cycle.
  21. Participation in an investigational drug study within one month.
  22. Any clinically significant conditions that would interfere or constitute a health hazard for the patient.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00349531

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248.615.45103 Boehringer Ingelheim Investigational Site
Kgs. Lyngby, Denmark
248.615.45102 Boehringer Ingelheim Investigational Site
København K, Denmark
248.615.45101 Boehringer Ingelheim Investigational Site
København NV, Denmark
248.615.45104 Boehringer Ingelheim Investigational Site
Vaerløse, Denmark
248.615.35101 Boehringer Ingelheim Investigational Site
Espoo, Finland
248.615.35104 Boehringer Ingelheim Investigational Site
Joensuu, Finland
248.615.35103 Boehringer Ingelheim Investigational Site
Lahti, Finland
248.615.35102 Boehringer Ingelheim Investigational Site
Oulu, Finland
248.615.49109 Boehringer Ingelheim Investigational Site
Berlin, Germany
248.615.49103 Boehringer Ingelheim Investigational Site
Berlin-Steglitz, Germany
248.615.49105 Boehringer Ingelheim Investigational Site
Görlitz, Germany
248.615.49108 Boehringer Ingelheim Investigational Site
Hattingen, Germany
248.615.49106 Boehringer Ingelheim Investigational Site
München, Germany
248.615.49102 Boehringer Ingelheim Investigational Site
Schwerin, Germany
248.615.49101 Boehringer Ingelheim Investigational Site
Ulm, Germany
248.615.49107 Boehringer Ingelheim Investigational Site
Witten, Germany
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Würzburg, Germany
BIrr, Ireland
248.615.35301 Boehringer Ingelheim Investigational Site
Carrigtwohill, Ireland
Castlecomer, Ireland
248.615.39007 Policlinico di Bari - Università di Bari
Bari, Italy
248.615.39006 Ospedale Civile di Dolo
Dolo (VE), Italy
248.615.39002 Ospedale S. Martino - A. O. Università di Genova
Genova, Italy
248.615.39008 Policlinico Gaetano Martino
Messina, Italy
248.615.39001 Istituto San Raffaele Turro
Milano, Italy
248.615.39004 IRCCS Fondazione Istituto Neurologico "C. Mondino"
Pavia, Italy
248.615.39005 Ospedale S. Chiara
Pisa, Italy
248.615.39003 A. O. Santa Maria della Misericordia
Udine, Italy
248.615.47101 Boehringer Ingelheim Investigational Site
Bekkestua, Norway
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Fevik, Norway
248.615.47104 Boehringer Ingelheim Investigational Site
Moelv, Norway
248.615.47103 Boehringer Ingelheim Investigational Site
Oslo, Norway
248.615.47105 Boehringer Ingelheim Investigational Site
Tvedestrand, Norway
248.615.3408 Hospital Nuestra Señora de Sonsoles
Avila, Spain
Maderid, Spain
248.615.3404 Hospital General Universitario Gregorio Marañón
Madrid, Spain
Madrid, Spain
Madrid, Spain
248.615.3403 Hospital General de Catalunya
San Cugat del Valles (Barcelona), Spain
248.615.46101 Boehringer Ingelheim Investigational Site
Göteborg, Sweden
248.615.46103 Boehringer Ingelheim Investigational Site
Göteborg, Sweden
248.615.46102 Boehringer Ingelheim Investigational Site
Hedemora, Sweden
248.615.46104 Boehringer Ingelheim Investigational Site
Örebro, Sweden
United Kingdom
248.615.44006 Boehringer Ingelheim Investigational Site
Buckshaw Village, Chorley, United Kingdom
248.615.44004 Boehringer Ingelheim Investigational Site
Cambridge, United Kingdom
248.615.44007 Boehringer Ingelheim Investigational Site
Manchester, United Kingdom
248.615.44009 Boehringer Ingelheim Investigational Site
Reading, United Kingdom
248.615.44002 Boehringer Ingelheim Investigational Site
Romford, United Kingdom
248.615.44005 Boehringer Ingelheim Investigational Site
West Green, Crawley, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00349531     History of Changes
Other Study ID Numbers: 248.615 
Study First Received: July 6, 2006
Last Updated: May 18, 2012
Health Authority: Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte
Great Britain: MHRA
Ireland: The Irish Medicines Board
Italy: Comitato Etico della Fondazione Centro S. Raffaele del Monte Tabor (IRCCS) di Milano
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Spain: Agencia Espanola del Medicamento y Productos Sanitarios
Sweden: Medical Products Agency
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 24, 2016