Efficacy and Safety of Pramipexole (PPX) in Moderate to Severe Idiopathic Restless Legs Syndrome (RLS) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00275457
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : October 31, 2013
Information provided by:
Boehringer Ingelheim

Brief Summary:
To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 week open label or double blind extension.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: pramipexole Phase 3

Detailed Description:

To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 weeks open label or double blind extension

Study Hypotheses:

Null hypothesis: No difference between pramipexole and placebo in RLSRS total score from baseline and no difference in the CGI-I responder rates at the end of the 6 weeks double-blind treatment.


Pramipexole vs. Placebo

Study Type : Interventional  (Clinical Trial)
Enrollment : 346 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Dose Titration Trial With 0.125-0.75 mg Pramipexole (Sifrol®) Orally to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome for 6 Weeks Followed by 46 Weeks Open-label or Double-blind Treatment Period
Study Start Date : October 2002
Actual Primary Completion Date : April 2004
Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
U.S. FDA Resources

Primary Outcome Measures :
  1. Mean change from baseline to week 6 on the RLSRS +
  2. CGI-I responders (much and very much improved)

Secondary Outcome Measures :
  1. RLRS responders, CGI, PGI responders, EPSS, QoL (SF-36) VAS severity of RLS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Male or female out-patients aged 18-80
  2. Diagnosis of idiopathic RLS according to the Clinical RLS criteria of the International RLS Study Group. All of the four criteria must be present:

    • Irresistible urge to move usually associated with sensory complaints of the lower limbs
    • Motor restlessness
    • Worsening of the symptoms at rest with at least partial and temporary relief by activity
    • Increased severity in the evening or at night
  3. RLS rating scale for severity score > 15
  4. RLS symptoms present at least 2 to 3 days per week within in the last 3 months
  5. Written informed consent consistent with ICH/GCP and local legislation given prior to any study procedures
  6. Ability and willingness to comply with study treatment regimen and to attend study assessments

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 or 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 or 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, or any women not having negative serum pregnancy test at screening
  2. Males not using an adequate form of contraception (condom, sterilisation at least 6 months post operation)
  3. Patients who are breastfeeding
  4. Concomitant or previous pharmacologically therapy of RLS as follows:

    • Any intake of levodopa within 5 days prior to baseline visit (V2)
    • Any intake of dopamine agonists within 14 days prior to baseline visit (V2)
    • History of any intake of pramipexole
  5. Current (less than 14 days before treatment with trial medication or concomitant) treatment with medication or dietary supplements, which could significantly influence RLS symptoms - withdrawal symptoms caused by stopping any of the drugs above
  6. Confirmed diagnose of diabetes mellitus requiring insulin therapy
  7. Clinically significant renal disease or creatinine higher than upper limit of normal (ULN) at screening
  8. Clinically significant hepatic disease or sGPT > 2 times the upper limit of normal range at screening
  9. Clinical or laboratory signs of microcytic anaemia at the investigators discretion
  10. Any of the following lab results at screening:

    • Hb or erythrocyte count below lower limit of normal (LLN)
    • Basal TSH, T3 or T4 clinically significantly (at the investigator's discretion) out of normal range at screening (if not caused by substitution therapy according the investigator's opinion)
  11. Other clinically significant metabolic-endocrine, haematological, gastro-intestinal disease or pulmonary disease. Poorly controlled cardiovascular disease
  12. History or clinical signs of peripheral neuropathy (PNP) of any origin in physical, neurological examination, myelopathy or multiple sclerosis or any other neurological disease, with potential to secondarily cause RLS symptoms
  13. Presence of any other sleep disorder, such as, REM sleep behaviour disorder, narcolepsy or sleep apnoea syndrome
  14. History of Schizophrenia or any psychotic disorder, history of mental disorders due to a general medical condition or any present axis I psychiatric disorder according DSM IV requiring any medical therapy or history of or alcohol abuse or drug addiction within the last 2 years before screening
  15. Participation in a drug study within two months prior to the start of this study
  16. History of or clinical signs for any form of epilepsy or seizures apart from fever related seizures in early childhood
  17. History of or clinical signs of malign neoplasm
  18. Patients on a shift-work-schedule, or who are otherwise unable to follow a regular sleep-wake cycle enabling use of study medication at times indicated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00275457

Univ.-Klinik für Neurologie
Graz, Austria, 8036
Univ.-Klinik für Neurologie
Innsbruck, Austria, 6020
AKH der Stadt Linz
Linz, Austria, 4021
Confraternität Privatklinik
Wien, Austria, 1080
AKH Universitätsklinik für Psychiatrie
Wien, Austria, 1090
Sonderkrankenanstalt für neurologischen und
Wien, Austria, 1130
Wilhelminenspital der Stadt Wien
Wien, Austria, 1160
Boehringer Ingelheim Investigational Site
Bad Dürrheim-Sunthausen, Germany, 78073
Boehringer Ingelheim Investigational Site
Bad Krozingen, Germany, 79189
Boehringer Ingelheim Investigational Site
Berlin, Germany, 10625
emovis GmbH
Berlin, Germany, 10629
Facharzt für Neurologie
Emmendingen, Germany, 79312
Boehringer Ingelheim Investigational Site
Kehl, Germany, 77694
ClinPharm International GmbH & Co. KG
Leipzig, Germany, 04229
Universitätsklinikum Giessen und Marburg
Marburg, Germany, 35039
Boehringer Ingelheim Investigational Site
Beek en Donk, Netherlands, 5741 AR
Boehringer Ingelheim Investigational Site
Den Haag, Netherlands, 2585 LJ
Boehringer Ingelheim Investigational Site
Deurne, Netherlands, 5751 XJ
Boehringer Ingelheim Investigational Site
Ewijk, Netherlands, 6644 CL
Boehringer Ingelheim Investigational Site
Lichtenvoorde, Netherlands, 7131 CM
Boehringer Ingelheim Investigational Site
Rijswijk, Netherlands, 2281 AK
Boehringer Ingelheim Investigational Site
Roelofarendsveen, Netherlands, 2371 RB
Boehringer Ingelheim Investigational Site
Rotterdam, Netherlands, 3082 DC
Boehringer Ingelheim Investigational Site
Hamar, Norway, N-2317
Boehringer Ingelheim Investigational Site
Oslo, Norway, N-0159
Boehringer Ingelheim Investigational Site
Oslo, Norway, N-0303
Boehringer Ingelheim Investigational Site
Tønsberg, Norway, N-3111
Boehringer Ingelheim Investigational Site
Göteborg, Sweden, 413 45
Stockholms Neuro Center
Stockholm, Sweden, 112 81
Stockholm, Sweden, 141 86
Boehringer Ingelheim Investigational Site
Uppsala, Sweden, 751 85
Läkarhuset Vällingby
Vällingby, Sweden, 162 68
Boehringer Ingelheim Investigational Site
Västra Frölunda, Sweden, 421 30
Boehringer Ingelheim Investigational Site
Örebro, Sweden, 701 85
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Pharma GmbH & Co. KG Identifier: NCT00275457     History of Changes
Other Study ID Numbers: 248.520
First Posted: January 12, 2006    Key Record Dates
Last Update Posted: October 31, 2013
Last Verified: October 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