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

Depression Clinical Trial

Official title:

A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With 0.125-0.75 mg/Day Pramipexole (Sifrol®, Mirapexin®) Orally for 12 Weeks to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome Associated With Mood Disturbances

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356096
• Other study ID #: 248.604
• Status: Completed
• Phase: Phase 4
• First received: July 24, 2006
• Last updated: May 18, 2012
• Start date: July 2006

Study information

• Verified date: May 2012
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyFrance: AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTEGermany: Bundesinstitut fuer Arzneimittel und MedizinprodukteGreat Britain: MHRAIreland: The Irish Medicines BoardItaly: Comitato Etico Indipendente dell'Az. USL di Bologna - BolognaKorea, Republic of: Korea Food and Drug Administration (KFDA)Spain: Agencia Espanola del Medicamento y Productos SanitariosSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Psychomotor Agitation
• Restless Legs Syndrome

Intervention

Drug:
• pramipexole

Locations

Country	Name	City	State
Finland	248.604.35801 Boehringer Ingelheim Investigational Site	Espoo
Finland	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
France	248.604.3301A HOP Le Vinatier,Psychiat,Bron	Bron
France	248.604.3304B Hôpital Roger Salengro	Lille cedex
France	248.604.3307A Cabinet Médical	Montbrison
France	248.604.3303A Hôpital Gui de Chauliac	Montpellier cédex 5
France	248.604.3303C Hôpital Gui de Chauliac	Montpellier cédex 5
France	248.604.3302A Hôpital Pitié Salpétrière	Paris cédex 13
France	248.604.3305B Hôpital du Haut Levêque	Pessac cédex
Germany	248.604.4902 Boehringer Ingelheim Investigational Site	Berlin
Germany	248.604.4904 Boehringer Ingelheim Investigational Site	Berlin
Germany	248.604.4905 Boehringer Ingelheim Investigational Site	Berlin
Germany	248.604.4906 Boehringer Ingelheim Investigational Site	Berlin
Germany	248.604.4903 Boehringer Ingelheim Investigational Site	Berlin (Hellersdorf)
Germany	248.604.4909 Boehringer Ingelheim Investigational Site	Chemnitz
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	248.604.4908 Boehringer Ingelheim Investigational Site	Marburg
Germany	248.604.4911 Boehringer Ingelheim Investigational Site	München
Ireland	248.604.35305	Carrigtwohill
Ireland	248.604.35302 Boehringer Ingelheim Investigational Site	Castledermot
Italy	248.604.3901 Università degli Studi di Bologna	Bologna
Italy	248.604.3905 Casa di Cura Villa Serena	Città S. Angelo (PE)
Italy	248.604.3906 Clinica Psichiatrica	Pisa
Italy	248.604.3902 IRCCS San Raffaele	Roma
Italy	248.604.3909 IRCCS Fondazione "Salvatore Maugeri"	Telese Terme (be)
Italy	248.604.3908 Azienda Sanitaria San Giovanni Battista	Torino
Italy	248.604.3904 IRCCS Oasi Maria SS	Troina (Enna)
Korea, Republic of	248.604.82001 Boehringer Ingelheim Investigational Site	Daegu
Korea, Republic of	248.604.82003 Boehringer Ingelheim Investigational Site	Incheon
Korea, Republic of	248.604.82002 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	248.604.82004 Boehringer Ingelheim Investigational Site	Seoul
Spain	248.604.3401	Madrid
Spain	248.604.3403	Madrid
Spain	248.604.3405	Madrid
Spain	248.604.3407	Oviedo
Spain	248.604.3402	San Cugat del Vallés (Barcelona)
Spain	248.604.3404 Hospital de Donostia	San Sebastián
Sweden	248.604.4602 Boehringer Ingelheim Investigational Site	Göteborg
Sweden	248.604.4603 Boehringer Ingelheim Investigational Site	Göteborg
Sweden	248.604.4601 Boehringer Ingelheim Investigational Site	Hedemora
Sweden	248.604.4605 Boehringer Ingelheim Investigational Site	Örebro
Sweden	248.604.4604 Boehringer Ingelheim Investigational Site	Skövde
Sweden	248.604.4606 Boehringer Ingelheim Investigational Site	Stockholm
United Kingdom	248.604.44004 Boehringer Ingelheim Investigational Site	Cambridge
United Kingdom	248.604.44006 Boehringer Ingelheim Investigational Site	Chorley
United Kingdom	248.604.44001 Boehringer Ingelheim Investigational Site	London
United Kingdom	248.604.44007 Boehringer Ingelheim Investigational Site	Manchester
United Kingdom	248.604.44009 Boehringer Ingelheim Investigational Site	Reading
United Kingdom	248.604.44002 Boehringer Ingelheim Investigational Site	Romford
United Kingdom	248.604.44005 Boehringer Ingelheim Investigational Site	West Green, Crawley

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Finland,  France,  Germany,  Ireland,  Italy,  Korea, Republic of,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

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