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

May 18, 2012 updated by: Boehringer Ingelheim

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: pramipexole

Study Type

Interventional

Enrollment (Actual)

404

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Finland
- - Espoo, Finland
    - 248.604.35801 Boehringer Ingelheim Investigational Site
  - Helsinki, Finland
    - 248.604.35805 Boehringer Ingelheim Investigational Site
  - Lahti, Finland
    - 248.604.35803 Boehringer Ingelheim Investigational Site
  - Oulu, Finland
    - 248.604.35802 Boehringer Ingelheim Investigational Site
France
- - Bron, France
    - 248.604.3301A HOP Le Vinatier,Psychiat,Bron
  - Lille cedex, France
    - 248.604.3304B Hôpital Roger Salengro
  - Montbrison, France
    - 248.604.3307A Cabinet Médical
  - Montpellier cédex 5, France
    - 248.604.3303A Hôpital Gui de Chauliac
  - Montpellier cédex 5, France
    - 248.604.3303C Hôpital Gui de Chauliac
  - Paris cédex 13, France
    - 248.604.3302A Hôpital Pitié Salpétrière
  - Pessac cédex, France
    - 248.604.3305B Hôpital du Haut Levêque
Germany
- - Berlin, 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 (Hellersdorf), Germany
    - 248.604.4903 Boehringer Ingelheim Investigational Site
  - Chemnitz, Germany
    - 248.604.4909 Boehringer Ingelheim Investigational Site
  - Freiburg, Germany
    - 248.604.4901 Boehringer Ingelheim Investigational Site
  - Kassel, Germany
    - 248.604.4907 Boehringer Ingelheim Investigational Site
  - Leipzig, Germany
    - 248.604.4910 Boehringer Ingelheim Investigational Site
  - Marburg, Germany
    - 248.604.4908 Boehringer Ingelheim Investigational Site
  - München, Germany
    - 248.604.4911 Boehringer Ingelheim Investigational Site
Ireland
- - Carrigtwohill, Ireland
    - 248.604.35305
  - Castledermot, Ireland
    - 248.604.35302 Boehringer Ingelheim Investigational Site
Italy
- - Bologna, Italy
    - 248.604.3901 Università degli Studi di Bologna
  - Città S. Angelo (PE), Italy
    - 248.604.3905 Casa di Cura Villa Serena
  - Pisa, Italy
    - 248.604.3906 Clinica Psichiatrica
  - Roma, Italy
    - 248.604.3902 IRCCS San Raffaele
  - Telese Terme (be), Italy
    - 248.604.3909 IRCCS Fondazione "Salvatore Maugeri"
  - Torino, Italy
    - 248.604.3908 Azienda Sanitaria San Giovanni Battista
  - Troina (Enna), Italy
    - 248.604.3904 IRCCS Oasi Maria SS
Korea, Republic of
- - Daegu, Korea, Republic of
    - 248.604.82001 Boehringer Ingelheim Investigational Site
  - Incheon, Korea, Republic of
    - 248.604.82003 Boehringer Ingelheim Investigational Site
  - Seoul, Korea, Republic of
    - 248.604.82002 Boehringer Ingelheim Investigational Site
  - Seoul, Korea, Republic of
    - 248.604.82004 Boehringer Ingelheim Investigational Site
Spain
- - Madrid, Spain
    - 248.604.3401
  - Madrid, Spain
    - 248.604.3403
  - Madrid, Spain
    - 248.604.3405
  - Oviedo, Spain
    - 248.604.3407
  - San Cugat del Vallés (Barcelona), Spain
    - 248.604.3402
  - San Sebastián, Spain
    - 248.604.3404 Hospital de Donostia
Sweden
- - Göteborg, Sweden
    - 248.604.4602 Boehringer Ingelheim Investigational Site
  - Göteborg, Sweden
    - 248.604.4603 Boehringer Ingelheim Investigational Site
  - Hedemora, Sweden
    - 248.604.4601 Boehringer Ingelheim Investigational Site
  - Skövde, Sweden
    - 248.604.4604 Boehringer Ingelheim Investigational Site
  - Stockholm, Sweden
    - 248.604.4606 Boehringer Ingelheim Investigational Site
  - Örebro, Sweden
    - 248.604.4605 Boehringer Ingelheim Investigational Site
United Kingdom
- - Cambridge, United Kingdom
    - 248.604.44004 Boehringer Ingelheim Investigational Site
  - Chorley, United Kingdom
    - 248.604.44006 Boehringer Ingelheim Investigational Site
  - London, United Kingdom
    - 248.604.44001 Boehringer Ingelheim Investigational Site
  - Manchester, United Kingdom
    - 248.604.44007 Boehringer Ingelheim Investigational Site
  - Reading, United Kingdom
    - 248.604.44009 Boehringer Ingelheim Investigational Site
  - Romford, United Kingdom
    - 248.604.44002 Boehringer Ingelheim Investigational Site
  - West Green, Crawley, United Kingdom
    - 248.604.44005 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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
History of/or any other sleep disorder
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
History of/or clinical signs of suicidal behaviour, suicide ideation or acute suicidal tendency according to the investigators opinion
History of/or alcohol abuse or drug addiction within the last 2 years before screening
Patients on a shift-work-schedule or otherwise unable to follow a regular sleep-wake cycle
Participation in an investigational drug study within one month prior to the start of this study
Patients with any clinically significant conditions that in the opinion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Time Frame: 12 weeks	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Time Frame: 12 weeks	12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

July 24, 2006

First Submitted That Met QC Criteria