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

NCT00349531 | Completed Phase 4

• 1 other identifier: 248.615
• Study Type: interventional
• Target: 369
• Locations: 9 countries
• Sites: 49

Brief Summary

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

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks after start of treatment

Secondary Outcomes (1)

• 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

  12 weeks after start of treatment

Interventions

Pramipexole DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Male or female out-patients aged 18-80 years.
• 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).
• RLS symptoms present at least 2 to 3 days per week during the last 3 months prior to baseline (Visit 2).
• IRLS total score \>15 at baseline (Visit 2).

You may not qualify if:

• Women of child-bearing potential who do not use during the trial an adequate method of contraception.
• Women of child-bearing potential not having negative pregnancy test at screening.
• Breastfeeding women.
• 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.
• All treatment less than 14 days or concomitant treatment with medication or dietary supplements which could significantly influence RLS symptoms.
• Withdrawal symptoms.
• Pramipexole non-responders in other indications than RLS.
• Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets.
• Diabetes mellitus requiring insulin therapy.
• Any of the following laboratory results at screening:
• any clinically significant abnormalities in laboratory parameters;
• haemoglobin below LLN.
• Clinically significant renal disease or calculated creatinine clearance lower than 30 mL/minute.
• Clinically significant hepatic disease or GPT \>2 times the ULN.
• Serum ferritin \<10 ng/mL.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (49)

248.615.45103 Boehringer Ingelheim Investigational Site

Kongens Lyngby, Denmark

Location

248.615.45102 Boehringer Ingelheim Investigational Site

København K, Denmark

Location

248.615.45101 Boehringer Ingelheim Investigational Site

København NV, Denmark

Location

248.615.45104 Boehringer Ingelheim Investigational Site

Vaerløse, Denmark

Location

248.615.35101 Boehringer Ingelheim Investigational Site

Espoo, Finland

Location

248.615.35104 Boehringer Ingelheim Investigational Site

Joensuu, Finland

Location

248.615.35103 Boehringer Ingelheim Investigational Site

Lahti, Finland

Location

248.615.35102 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

248.615.49109 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

248.615.49105 Boehringer Ingelheim Investigational Site

Görlitz, Germany

Location

248.615.49108 Boehringer Ingelheim Investigational Site

Hattingen, Germany

Location

248.615.49106 Boehringer Ingelheim Investigational Site

München, Germany

Location

248.615.49102 Boehringer Ingelheim Investigational Site

Schwerin, Germany

Location

248.615.49103 Boehringer Ingelheim Investigational Site

Steglitz, Germany

Location

248.615.49101 Boehringer Ingelheim Investigational Site

Ulm, Germany

Location

248.615.49107 Boehringer Ingelheim Investigational Site

Witten, Germany

Location

248.615.49104 Boehringer Ingelheim Investigational Site

Würzburg, Germany

Location

248.615.35302

Birr, Ireland

Location

248.615.35301 Boehringer Ingelheim Investigational Site

Carrigtohill, Ireland

Location

248.615.35303

Castlecomer, Ireland

Location

248.615.39007 Policlinico di Bari - Università di Bari

Bari, Italy

Location

248.615.39006 Ospedale Civile di Dolo

Dolo (VE), Italy

Location

248.615.39002 Ospedale S. Martino - A. O. Università di Genova

Genova, Italy

Location

248.615.39008 Policlinico Gaetano Martino

Messina, Italy

Location

248.615.39001 Istituto San Raffaele Turro

Milan, Italy

Location

248.615.39004 IRCCS Fondazione Istituto Neurologico "C. Mondino"

Pavia, Italy

Location

248.615.39005 Ospedale S. Chiara

Pisa, Italy

Location

248.615.39003 A. O. Santa Maria della Misericordia

Udine, Italy

Location

248.615.47101 Boehringer Ingelheim Investigational Site

Bekkestua, Norway

Location

248.615.47102 Boehringer Ingelheim Investigational Site

Fevik, Norway

Location

248.615.47104 Boehringer Ingelheim Investigational Site

Moelv, Norway

Location

248.615.47103 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

248.615.47105 Boehringer Ingelheim Investigational Site

Tvedestrand, Norway

Location

248.615.3408 Hospital Nuestra Señora de Sonsoles

Ávila, Spain

Location

248.615.3402

Maderid, Spain

Location

248.615.3404 Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

248.615.3406

Madrid, Spain

Location

248.615.3407

Madrid, Spain

Location

248.615.3403 Hospital General de Catalunya

San Cugat Del Valles (Barcelona), Spain

Location

248.615.46101 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

248.615.46103 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

248.615.46102 Boehringer Ingelheim Investigational Site

Hedemora, Sweden

Location

248.615.46104 Boehringer Ingelheim Investigational Site

Örebro, Sweden

Location

248.615.44006 Boehringer Ingelheim Investigational Site

Buckshaw Village, Chorley, United Kingdom

Location

248.615.44004 Boehringer Ingelheim Investigational Site

Cambridge, United Kingdom

Location

248.615.44007 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

248.615.44009 Boehringer Ingelheim Investigational Site

Reading, United Kingdom

Location

248.615.44002 Boehringer Ingelheim Investigational Site

Romford, United Kingdom

Location

248.615.44005 Boehringer Ingelheim Investigational Site

West Green, Crawley, United Kingdom

Location

Related Publications (1)

• Hornyak M, Sohr M, Busse M; 604 and 615 Study Groups. Evaluation of painful sensory symptoms in restless legs syndrome: experience from two clinical trials. Sleep Med. 2011 Feb;12(2):186-9. doi: 10.1016/j.sleep.2010.11.007. Epub 2011 Jan 21.

  PMID: 21256799 DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 6, 2006
• First Posted: July 7, 2006
• Study Start: July 1, 2006
• Primary Completion: May 1, 2007
• Last Updated: May 21, 2012

Record last verified: 2012-05

Locations

DE (9); SE (4); GB (6); IT (8); DK (4); IE (3); NO (5); ES (6); FI (4)