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

Phase 4

Completed

• Conditions: Restless Legs Syndrome; Depression

• Registration Number: NCT00356096
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-24
• Study First Submitted QC: 2006-07-24
• Study First Posted: 2006-07-25
• Primary Completion: 2007-06
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-18
• Last Update Posted: 2012-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 404

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. 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

Exclusion Criteria

1. Women of child-bearing potential who do not use an adequate method of contraception
2. Any women of child-bearing potential not having negative pregnancy test at screening
3. Breastfeeding women
4. Concomitant or previous pharmacologic therapy for RLS
5. All treatment less than 14 days before baseline or concomitant treatment with medication or dietary supplements, which could significantly influence RLS symptoms
6. Withdrawal symptoms of any medication must not be present at baseline
7. Previous pramipexole non-responders in other indications than RLS.
8. Hypersensitivity to pramipexole or any other component of the investigational product
9. Diagnosis of diabetes mellitus requiring insulin
10. Any of the following laboratory results at screening: clinically significant abnormalities at the investigatos discretion; Hb below lower limit of normal
11. Clinically significant renal disease at screening
12. Clinically significant hepatic disease at screening
13. Serum ferritin <10 ng/mL at screening.
14. History of/or malignant melanoma.
15. History of/or clinically significant vision abnormalities
16. History of/or any other sleep disorder
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, or BDI-II total score >28
18. History of/or clinical signs of suicidal behaviour, suicide ideation or acute suicidal tendency according to the investigators opinion
19. History of/or alcohol abuse or drug addiction within the last 2 years before screening
20. Patients on a shift-work-schedule or otherwise unable to follow a regular sleep-wake cycle
21. Participation in an investigational drug study within one month prior to the start of this study
22. Patients with any clinically significant conditions that in the opinion of the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (54)

248.604.35801 Boehringer Ingelheim Investigational Site; 🇫🇮 Espoo, Finland

248.604.82003 Boehringer Ingelheim Investigational Site; 🇰🇷 Incheon, Korea, Republic of

248.604.3909 IRCCS Fondazione "Salvatore Maugeri"; 🇮🇹 Telese Terme (be), Italy

248.604.3905 Casa di Cura Villa Serena; 🇮🇹 Città S. Angelo (PE), Italy

248.604.3908 Azienda Sanitaria San Giovanni Battista; 🇮🇹 Torino, Italy

248.604.3906 Clinica Psichiatrica; 🇮🇹 Pisa, Italy

248.604.3904 IRCCS Oasi Maria SS; 🇮🇹 Troina (Enna), Italy

248.604.4605 Boehringer Ingelheim Investigational Site; 🇸🇪 Örebro, Sweden

248.604.3402; 🇪🇸 San Cugat del Vallés (Barcelona), Spain

248.604.3404 Hospital de Donostia; 🇪🇸 San Sebastián, Spain

248.604.3403; 🇪🇸 Madrid, Spain

248.604.3405; 🇪🇸 Madrid, Spain

248.604.3902 IRCCS San Raffaele; 🇮🇹 Roma, Italy

248.604.82004 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

248.604.82001 Boehringer Ingelheim Investigational Site; 🇰🇷 Daegu, Korea, Republic of

248.604.3401; 🇪🇸 Madrid, Spain

248.604.82002 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

248.604.4601 Boehringer Ingelheim Investigational Site; 🇸🇪 Hedemora, Sweden

248.604.4606 Boehringer Ingelheim Investigational Site; 🇸🇪 Stockholm, Sweden

248.604.44006 Boehringer Ingelheim Investigational Site; 🇬🇧 Chorley, United Kingdom

248.604.3407; 🇪🇸 Oviedo, Spain

248.604.4602 Boehringer Ingelheim Investigational Site; 🇸🇪 Göteborg, Sweden

248.604.4604 Boehringer Ingelheim Investigational Site; 🇸🇪 Skövde, Sweden

248.604.44007 Boehringer Ingelheim Investigational Site; 🇬🇧 Manchester, United Kingdom

248.604.44004 Boehringer Ingelheim Investigational Site; 🇬🇧 Cambridge, United Kingdom

248.604.44001 Boehringer Ingelheim Investigational Site; 🇬🇧 London, United Kingdom

248.604.4603 Boehringer Ingelheim Investigational Site; 🇸🇪 Göteborg, Sweden

248.604.44009 Boehringer Ingelheim Investigational Site; 🇬🇧 Reading, United Kingdom

248.604.35805 Boehringer Ingelheim Investigational Site; 🇫🇮 Helsinki, Finland

248.604.35803 Boehringer Ingelheim Investigational Site; 🇫🇮 Lahti, Finland

248.604.35802 Boehringer Ingelheim Investigational Site; 🇫🇮 Oulu, Finland

248.604.3304B Hôpital Roger Salengro; 🇫🇷 Lille cedex, France

248.604.3307A Cabinet Médical; 🇫🇷 Montbrison, France

248.604.3301A HOP Le Vinatier,Psychiat,Bron; 🇫🇷 Bron, France

248.604.3303A Hôpital Gui de Chauliac; 🇫🇷 Montpellier cédex 5, France

248.604.3303C Hôpital Gui de Chauliac; 🇫🇷 Montpellier cédex 5, France

248.604.4904 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

248.604.3302A Hôpital Pitié Salpétrière; 🇫🇷 Paris cédex 13, France

248.604.3305B Hôpital du Haut Levêque; 🇫🇷 Pessac cédex, France

248.604.4903 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin (Hellersdorf), Germany

248.604.4902 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

248.604.4906 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

248.604.4909 Boehringer Ingelheim Investigational Site; 🇩🇪 Chemnitz, Germany

248.604.4908 Boehringer Ingelheim Investigational Site; 🇩🇪 Marburg, Germany

248.604.4905 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

248.604.4901 Boehringer Ingelheim Investigational Site; 🇩🇪 Freiburg, Germany

248.604.4907 Boehringer Ingelheim Investigational Site; 🇩🇪 Kassel, Germany

248.604.4910 Boehringer Ingelheim Investigational Site; 🇩🇪 Leipzig, Germany

248.604.3901 Università degli Studi di Bologna; 🇮🇹 Bologna, Italy

248.604.35302 Boehringer Ingelheim Investigational Site; 🇮🇪 Castledermot, Ireland

248.604.4911 Boehringer Ingelheim Investigational Site; 🇩🇪 München, Germany

248.604.35305; 🇮🇪 Carrigtwohill, Ireland

248.604.44002 Boehringer Ingelheim Investigational Site; 🇬🇧 Romford, United Kingdom

248.604.44005 Boehringer Ingelheim Investigational Site; 🇬🇧 West Green, Crawley, United Kingdom