A Randomized, Double-blind, Placebo Controlled Dose Titration Trial With 0.125-0.75 mg Pramipexole (Sifrol®) Orally q.n. to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome for 6 Weeks

Boehringer Ingelheim16 sites in 1 country306 target enrollmentApril 2008

ConditionsRestless Legs Syndrome

InterventionsPramipexole Placebo

DrugsPramipexole Placebo

Overview

Phase: Phase 3
Intervention: Pramipexole
Conditions: Restless Legs Syndrome
Sponsor: Boehringer Ingelheim
Enrollment: 306
Locations: 16
Primary Endpoint: The Change From Baseline to Week 6 in the Total Score of Restless Legs Syndrome Rating Scale for Severity of the International Restless Legs Syndrome Study Group (IRLS).
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To determine efficacy and safety of Pramipexole 0.125mg to 0.75mg daily for 6 weeks compared to placebo in the treatment of idiopathic Restless Legs Syndrome (RLS)

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

June 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent consistent with International Conference on Harmonisation (ICH) / Good Clinical Practice (GCP) and local legislation given prior to any study procedures.
•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 Restless Legs Syndrome (IRLS) according to the clinical Restless Legs Syndrome (RLS) criteria of the International Restless Legs Syndrome Study Group (IRLSSG)
•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).
•Restless Legs Syndrome (RLS)rating scale for severity total score \>

Exclusion Criteria

•Women of child-bearing potential (i.e. premenopausal women, or postmenopausal women less than 2 years after last menses) who do not use during the clinical trial an adequate method of contraception such as: hormonal therapy (combined oral contraceptives, injectables, or subcutaneous implants), hormonal intrauterine devices, sexual abstinence, surgical sterilization of patient and/or partner, hysterectomy, bilateral ovariectomy or partners vasectomy
•Any woman of child-bearing potential not having a negative pregnancy test at screening
•Patients who are breastfeeding
•Concomitant or previous pharmacologically therapy of RLS as follows:
•Any intake of levodopa within 5 days prior to baseline visit (V2)
•Any intake of dopamine agonists within 14 days prior to baseline visit (V2)
•Current (less than 14 days before treatment with trial medication or concomitant) treatment with medication or dietary supplements, which could significantly influence RLS symptoms, e.g. dopaminergic (other than levodopa or dopamine agonists) or anti-dopaminergic drugs, non-selective Monoamine Oxidase (MAO) inhibitors, sympathomimetics, neuroleptics, anti-depressants, hypnotics, any benzodiazepines, antiepileptics, opioids, clonidine, magnesium, ferrous salts, Folic acid, vitamin B12, antihistaminics, lithium, metoclopramide or Withdrawal symptoms caused by stopping any of the drugs above
•Confirmed diagnose of diabetic nephropathy or clinically significant renal disease
•Creatinine higher than upper limit of normal (ULN) at screening
•Clinical significant hepatic disease or Alanine aminotransferase (ALT) \>2 times the upper limit of normal range at screening

Arms & Interventions

Pramipexole

4 weeks of individual dose titration starting with Pramipexole 0.125 mg, next dose steps 0.25 mg, 0.5 mg and 0.75 mg, fixed dose for 2 weeks, once daily

Intervention: Pramipexole

Placebo

4 weeks of individual dose titration as for the investigational product, once daily

Intervention: Placebo

Outcomes

Primary Outcomes

The Change From Baseline to Week 6 in the Total Score of Restless Legs Syndrome Rating Scale for Severity of the International Restless Legs Syndrome Study Group (IRLS).

Time Frame: Baseline and 6 weeks of treatment

The IRLS was a 10-item self patient's rating scale for assessing severity of restless legs syndrome symptoms with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 (no symptoms) to 40 (worst possible symptoms).

The Proportion of Patients With Clinical Global Impressions -Improvement Scale (CGI-I) Assessment of "Much Improved" and "Very Much Improved"

Time Frame: 6 weeks of treatment

CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved)and 2 (much improved.

Secondary Outcomes

The Proportion of IRLS Responders(6 weeks of treatment)
The Proportion of Patient Global Impression(PGI) Responders(6 weeks of treatment)
The Proportion of Patients With Epworth Sleepiness Scale (ESS) Categorised >10(week 6 of treatment)
the Mean Change From Baseline to Week 6 in Satisfaction of Sleep at Night of RLS-6 Rating Scales(Baseline and 6 weeks of treatment)
The Mean Change From Baseline in the Severity of RLS at Time of Falling Sleep of RLS-6 Rating Scales.(Baseline and 6 weeks of treatment)
The Mean Change From Baseline in the Severity of RLS During the Night of RLS-6 Rating Scales.(Baseline and 6 weeks of treatment)
The Mean Change From Baseline in the Severity of RLS During the Rest at Day of RLS-6 Rating Scales.(Baseline and 6 weeks of treatment)
The Mean Change From Baseline in the Severity of RLS During the Activities at Day of RLS-6 Rating Scale(Baseline and 6 weeks of treatment)
The Mean Change From Baseline in the Intensity of Tiredness and Sleepiness at Day of RLS-6 Rating Scale(Baseline and 6 weeks of treatment)
The Change From Baseline in Visual Analogue Scales (VAS)(Baseline and 6 weeks of treatment)