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

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT00349531

Collaborator

(none)

369

Enrollment

Locations

7.5

Patients Per Site

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Restless Legs Syndrome	Drug: Pramipexole	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

369 participants

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).
IRLS total score >15 at baseline (Visit 2).

Exclusion Criteria:

Women of child-bearing potential who do not use during the trial an adequate method of contraception.
Women of child-bearing potential not having negative pregnancy test at screening.
Breastfeeding women.
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.
All treatment less than 14 days or concomitant treatment with medication or dietary supplements which could significantly influence RLS symptoms.
Withdrawal symptoms.
Pramipexole non-responders in other indications than RLS.
Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets.
Diabetes mellitus requiring insulin therapy.
Any of the following laboratory results at screening:

any clinically significant abnormalities in laboratory parameters;
haemoglobin below LLN.

Clinically significant renal disease or calculated creatinine clearance lower than 30 mL/minute.
Clinically significant hepatic disease or GPT >2 times the ULN.
Serum ferritin <10 ng/mL.
History of/or malignant melanoma.
History of/or clinically significant vision abnormalities.
History of/or any other sleep disorder (other than RLS-related).
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.
History of/or clinical signs of suicidal behaviour, suicide ideation or acute suicidal tendency according to the investigator's opinion.
History of/or alcohol abuse or drug addiction (within 2 years).
Patients on a shift-work-schedule or who are otherwise unable to follow a regular sleep-wake cycle.
Participation in an investigational drug study within one month.
Any clinically significant conditions that would interfere or constitute a health hazard for the patient.

Contacts and Locations

Locations

	Site	City	Country
1	248.615.45103 Boehringer Ingelheim Investigational Site	Kgs. Lyngby	Denmark
2	248.615.45102 Boehringer Ingelheim Investigational Site	København K	Denmark
3	248.615.45101 Boehringer Ingelheim Investigational Site	København NV	Denmark
4	248.615.45104 Boehringer Ingelheim Investigational Site	Vaerløse	Denmark
5	248.615.35101 Boehringer Ingelheim Investigational Site	Espoo	Finland
6	248.615.35104 Boehringer Ingelheim Investigational Site	Joensuu	Finland
7	248.615.35103 Boehringer Ingelheim Investigational Site	Lahti	Finland
8	248.615.35102 Boehringer Ingelheim Investigational Site	Oulu	Finland
9	248.615.49103 Boehringer Ingelheim Investigational Site	Berlin-Steglitz	Germany
10	248.615.49109 Boehringer Ingelheim Investigational Site	Berlin	Germany
11	248.615.49105 Boehringer Ingelheim Investigational Site	Görlitz	Germany
12	248.615.49108 Boehringer Ingelheim Investigational Site	Hattingen	Germany
13	248.615.49106 Boehringer Ingelheim Investigational Site	München	Germany
14	248.615.49102 Boehringer Ingelheim Investigational Site	Schwerin	Germany
15	248.615.49101 Boehringer Ingelheim Investigational Site	Ulm	Germany
16	248.615.49107 Boehringer Ingelheim Investigational Site	Witten	Germany
17	248.615.49104 Boehringer Ingelheim Investigational Site	Würzburg	Germany
18	248.615.35302	BIrr	Ireland
19	248.615.35301 Boehringer Ingelheim Investigational Site	Carrigtwohill	Ireland
20	248.615.35303	Castlecomer	Ireland
21	248.615.39007 Policlinico di Bari - Università di Bari	Bari	Italy
22	248.615.39006 Ospedale Civile di Dolo	Dolo (VE)	Italy
23	248.615.39002 Ospedale S. Martino - A. O. Università di Genova	Genova	Italy
24	248.615.39008 Policlinico Gaetano Martino	Messina	Italy
25	248.615.39001 Istituto San Raffaele Turro	Milano	Italy
26	248.615.39004 IRCCS Fondazione Istituto Neurologico "C. Mondino"	Pavia	Italy
27	248.615.39005 Ospedale S. Chiara	Pisa	Italy
28	248.615.39003 A. O. Santa Maria della Misericordia	Udine	Italy
29	248.615.47101 Boehringer Ingelheim Investigational Site	Bekkestua	Norway
30	248.615.47102 Boehringer Ingelheim Investigational Site	Fevik	Norway
31	248.615.47104 Boehringer Ingelheim Investigational Site	Moelv	Norway
32	248.615.47103 Boehringer Ingelheim Investigational Site	Oslo	Norway
33	248.615.47105 Boehringer Ingelheim Investigational Site	Tvedestrand	Norway
34	248.615.3408 Hospital Nuestra Señora de Sonsoles	Avila	Spain
35	248.615.3402	Maderid	Spain
36	248.615.3404 Hospital General Universitario Gregorio Marañón	Madrid	Spain
37	248.615.3406	Madrid	Spain
38	248.615.3407	Madrid	Spain
39	248.615.3403 Hospital General de Catalunya	San Cugat del Valles (Barcelona)	Spain
40	248.615.46101 Boehringer Ingelheim Investigational Site	Göteborg	Sweden
41	248.615.46103 Boehringer Ingelheim Investigational Site	Göteborg	Sweden
42	248.615.46102 Boehringer Ingelheim Investigational Site	Hedemora	Sweden
43	248.615.46104 Boehringer Ingelheim Investigational Site	Örebro	Sweden
44	248.615.44006 Boehringer Ingelheim Investigational Site	Buckshaw Village, Chorley	United Kingdom
45	248.615.44004 Boehringer Ingelheim Investigational Site	Cambridge	United Kingdom
46	248.615.44007 Boehringer Ingelheim Investigational Site	Manchester	United Kingdom
47	248.615.44009 Boehringer Ingelheim Investigational Site	Reading	United Kingdom
48	248.615.44002 Boehringer Ingelheim Investigational Site	Romford	United Kingdom
49	248.615.44005 Boehringer Ingelheim Investigational Site	West Green, Crawley	United Kingdom