Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances

NCT00356096 | Completed Phase 4

• 1 other identifier: 248.604
• Study Type: interventional
• Target: 404
• Locations: 9 countries
• Sites: 54

Brief Summary

The primary objective of this study is to determine the efficacy of pramipexole 0.125 mg to 0.75 mg daily versus placebo on RLS symptoms and on associated mood disturbances and depressive symptoms, after 12 weeks of treatment

Conditions

Restless Legs Syndrome; Depression

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the change from baseline after 12 weeks of treatment in: IRLS total score, IRLS item 10 score and BDI-II total score

  12 weeks

Secondary Outcomes (1)

• The following endpoints will be analysed: CGI-I, IRLS and BDI-II responder rate, VAS score for pain in limbs, RLS-6 item scores, HADS-A score, RLS-QoL score, PGI responder rate, Adverse events profile, Systolic and diastolic blood pressure, Pulse rate

  12 weeks

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).
• In addition all of the following must be demonstrated at Visit 2 (baseline):
• IRLS total score \>15 A score of \>=2 for item 10 of the IRLS rating scale

You may not qualify if:

• Women of child-bearing potential who do not use an adequate method of contraception
• Any women of child-bearing potential not having negative pregnancy test at screening
• Breastfeeding women
• Concomitant or previous pharmacologic therapy for RLS
• All treatment less than 14 days before baseline or concomitant treatment with medication or dietary supplements, which could significantly influence RLS symptoms
• Withdrawal symptoms of any medication must not be present at baseline
• Previous pramipexole non-responders in other indications than RLS.
• Hypersensitivity to pramipexole or any other component of the investigational product
• Diagnosis of diabetes mellitus requiring insulin
• Any of the following laboratory results at screening: clinically significant abnormalities at the investigatos discretion; Hb below lower limit of normal
• Clinically significant renal disease at screening
• Clinically significant hepatic disease at screening
• Serum ferritin \<10 ng/mL at screening.
• History of/or malignant melanoma.
• History of/or clinically significant vision abnormalities

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (54)

248.604.35801 Boehringer Ingelheim Investigational Site

Espoo, Finland

Location

248.604.35805 Boehringer Ingelheim Investigational Site

Helsinki, Finland

Location

248.604.35803 Boehringer Ingelheim Investigational Site

Lahti, Finland

Location

248.604.35802 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

248.604.3301A HOP Le Vinatier,Psychiat,Bron

Bron, France

Location

248.604.3304B Hôpital Roger Salengro

Lille, France

Location

248.604.3307A Cabinet Médical

Montbrison, France

Location

248.604.3303A Hôpital Gui de Chauliac

Montpellier Cédex 5, France

Location

248.604.3303C Hôpital Gui de Chauliac

Montpellier Cédex 5, France

Location

248.604.3302A Hôpital Pitié Salpétrière

Paris Cédex 13, France

Location

248.604.3305B Hôpital du Haut Levêque

Pessac Cédex, France

Location

248.604.4902 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

248.604.4904 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

248.604.4905 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

248.604.4906 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

248.604.4909 Boehringer Ingelheim Investigational Site

Chemnitz, Germany

Location

248.604.4901 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, Germany

Location

248.604.4903 Boehringer Ingelheim Investigational Site

Hellersdorf, Germany

Location

248.604.4907 Boehringer Ingelheim Investigational Site

Kassel, Germany

Location

248.604.4910 Boehringer Ingelheim Investigational Site

Leipzig, Germany

Location

248.604.4908 Boehringer Ingelheim Investigational Site

Marburg, Germany

Location

248.604.4911 Boehringer Ingelheim Investigational Site

München, Germany

Location

248.604.35305

Carrigtohill, Ireland

Location

248.604.35302 Boehringer Ingelheim Investigational Site

Castledermot, Ireland

Location

248.604.3901 Università degli Studi di Bologna

Bologna, Italy

Location

248.604.3905 Casa di Cura Villa Serena

Città S. Angelo (PE), Italy

Location

248.604.3906 Clinica Psichiatrica

Pisa, Italy

Location

248.604.3902 IRCCS San Raffaele

Roma, Italy

Location

248.604.3909 IRCCS Fondazione "Salvatore Maugeri"

Telese Terme (be), Italy

Location

248.604.3908 Azienda Sanitaria San Giovanni Battista

Torino, Italy

Location

248.604.3904 IRCCS Oasi Maria SS

Troina (Enna), Italy

Location

248.604.82001 Boehringer Ingelheim Investigational Site

Daegu, South Korea

Location

248.604.82003 Boehringer Ingelheim Investigational Site

Incheon, South Korea

Location

248.604.82002 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

248.604.82004 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

248.604.3401

Madrid, Spain

Location

248.604.3403

Madrid, Spain

Location

248.604.3405

Madrid, Spain

Location

248.604.3407

Oviedo, Spain

Location

248.604.3402

San Cugat Del Vallés (Barcelona), Spain

Location

248.604.3404 Hospital de Donostia

San Sebastián, Spain

Location

248.604.4602 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

248.604.4603 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

248.604.4601 Boehringer Ingelheim Investigational Site

Hedemora, Sweden

Location

248.604.4605 Boehringer Ingelheim Investigational Site

Örebro, Sweden

Location

248.604.4604 Boehringer Ingelheim Investigational Site

Skövde, Sweden

Location

248.604.4606 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

248.604.44004 Boehringer Ingelheim Investigational Site

Cambridge, United Kingdom

Location

248.604.44006 Boehringer Ingelheim Investigational Site

Chorley, United Kingdom

Location

248.604.44001 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

248.604.44007 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

248.604.44009 Boehringer Ingelheim Investigational Site

Reading, United Kingdom

Location

248.604.44002 Boehringer Ingelheim Investigational Site

Romford, United Kingdom

Location

248.604.44005 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; Depression

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

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

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 24, 2006
• First Posted: July 25, 2006
• Study Start: July 1, 2006
• Primary Completion: June 1, 2007
• Last Updated: May 21, 2012

Record last verified: 2012-05

Locations

IT (7); DE (11); FR (7); FI (4); GB (7); KR (4); SE (6); ES (6); IE (2)