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

Restless Legs Syndrome Clinical Trial

Official title:

A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With Pramipexole (Sifrol®, Mirapexin®) 0.125-0.75 mg/Day Per os for 12 Weeks to Investigate the Effects on RLS Symptoms (IRLS) and Sleep Disturbance (MOS Sleep Scale) in Out-patients With Idiopathic Restless Legs Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349531
• Other study ID #: 248.615
• Status: Completed
• Phase: Phase 4
• First received: July 6, 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: Denmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyGermany: Bundesinstitut fuer Arzneimittel und MedizinprodukteGreat Britain: MHRAIreland: The Irish Medicines BoardItaly: Comitato Etico della Fondazione Centro S. Raffaele del Monte Tabor (IRCCS) di MilanoNorway: Norwegian Medicines Agency (Statens Legemiddelverk)Spain: Agencia Espanola del Medicamento y Productos SanitariosSweden: Medical Products AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 369
• Est. primary completion date: May 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. IRLS total score >15 at baseline (Visit 2).

Exclusion Criteria:

1. Women of child-bearing potential who do not use during the trial an adequate method of contraception.

2. Women of child-bearing potential not having negative pregnancy test at screening.

3. Breastfeeding women.

4. 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.

5. All treatment less than 14 days or concomitant treatment with medication or dietary supplements which could significantly influence RLS symptoms.

6. Withdrawal symptoms.

7. Pramipexole non-responders in other indications than RLS.

8. Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets.

9. Diabetes mellitus requiring insulin therapy.

10. Any of the following laboratory results at screening:

• any clinically significant abnormalities in laboratory parameters;

• haemoglobin below LLN.

11. Clinically significant renal disease or calculated creatinine clearance lower than 30 mL/minute.

12. Clinically significant hepatic disease or GPT >2 times the ULN.

13. Serum ferritin <10 ng/mL.

14. History of/or malignant melanoma.

15. History of/or clinically significant vision abnormalities.

16. History of/or any other sleep disorder (other than RLS-related).

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.

18. History of/or clinical signs of suicidal behaviour, suicide ideation or acute suicidal tendency according to the investigator's opinion.

19. History of/or alcohol abuse or drug addiction (within 2 years).

20. Patients on a shift-work-schedule or who are otherwise unable to follow a regular sleep-wake cycle.

21. Participation in an investigational drug study within one month.

22. Any clinically significant conditions that would interfere or constitute a health hazard for the patient.

Study Design

Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Psychomotor Agitation
• Restless Legs Syndrome
• Sleep Disorders

Intervention

Drug:
• Pramipexole

Locations

Country	Name	City	State
Denmark	248.615.45103 Boehringer Ingelheim Investigational Site	Kgs. Lyngby
Denmark	248.615.45102 Boehringer Ingelheim Investigational Site	København K
Denmark	248.615.45101 Boehringer Ingelheim Investigational Site	København NV
Denmark	248.615.45104 Boehringer Ingelheim Investigational Site	Vaerløse
Finland	248.615.35101 Boehringer Ingelheim Investigational Site	Espoo
Finland	248.615.35104 Boehringer Ingelheim Investigational Site	Joensuu
Finland	248.615.35103 Boehringer Ingelheim Investigational Site	Lahti
Finland	248.615.35102 Boehringer Ingelheim Investigational Site	Oulu
Germany	248.615.49109 Boehringer Ingelheim Investigational Site	Berlin
Germany	248.615.49103 Boehringer Ingelheim Investigational Site	Berlin-Steglitz
Germany	248.615.49105 Boehringer Ingelheim Investigational Site	Görlitz
Germany	248.615.49108 Boehringer Ingelheim Investigational Site	Hattingen
Germany	248.615.49106 Boehringer Ingelheim Investigational Site	München
Germany	248.615.49102 Boehringer Ingelheim Investigational Site	Schwerin
Germany	248.615.49101 Boehringer Ingelheim Investigational Site	Ulm
Germany	248.615.49107 Boehringer Ingelheim Investigational Site	Witten
Germany	248.615.49104 Boehringer Ingelheim Investigational Site	Würzburg
Ireland	248.615.35302	BIrr
Ireland	248.615.35301 Boehringer Ingelheim Investigational Site	Carrigtwohill
Ireland	248.615.35303	Castlecomer
Italy	248.615.39007 Policlinico di Bari - Università di Bari	Bari
Italy	248.615.39006 Ospedale Civile di Dolo	Dolo (VE)
Italy	248.615.39002 Ospedale S. Martino - A. O. Università di Genova	Genova
Italy	248.615.39008 Policlinico Gaetano Martino	Messina
Italy	248.615.39001 Istituto San Raffaele Turro	Milano
Italy	248.615.39004 IRCCS Fondazione Istituto Neurologico "C. Mondino"	Pavia
Italy	248.615.39005 Ospedale S. Chiara	Pisa
Italy	248.615.39003 A. O. Santa Maria della Misericordia	Udine
Norway	248.615.47101 Boehringer Ingelheim Investigational Site	Bekkestua
Norway	248.615.47102 Boehringer Ingelheim Investigational Site	Fevik
Norway	248.615.47104 Boehringer Ingelheim Investigational Site	Moelv
Norway	248.615.47103 Boehringer Ingelheim Investigational Site	Oslo
Norway	248.615.47105 Boehringer Ingelheim Investigational Site	Tvedestrand
Spain	248.615.3408 Hospital Nuestra Señora de Sonsoles	Avila
Spain	248.615.3402	Maderid
Spain	248.615.3404 Hospital General Universitario Gregorio Marañón	Madrid
Spain	248.615.3406	Madrid
Spain	248.615.3407	Madrid
Spain	248.615.3403 Hospital General de Catalunya	San Cugat del Valles (Barcelona)
Sweden	248.615.46101 Boehringer Ingelheim Investigational Site	Göteborg
Sweden	248.615.46103 Boehringer Ingelheim Investigational Site	Göteborg
Sweden	248.615.46102 Boehringer Ingelheim Investigational Site	Hedemora
Sweden	248.615.46104 Boehringer Ingelheim Investigational Site	Örebro
United Kingdom	248.615.44006 Boehringer Ingelheim Investigational Site	Buckshaw Village, Chorley
United Kingdom	248.615.44004 Boehringer Ingelheim Investigational Site	Cambridge
United Kingdom	248.615.44007 Boehringer Ingelheim Investigational Site	Manchester
United Kingdom	248.615.44009 Boehringer Ingelheim Investigational Site	Reading
United Kingdom	248.615.44002 Boehringer Ingelheim Investigational Site	Romford
United Kingdom	248.615.44005 Boehringer Ingelheim Investigational Site	West Green, Crawley

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Denmark,  Finland,  Germany,  Ireland,  Italy,  Norway,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Link