Restless Legs Syndrome MedDRA version: 8.1 Level: pref Classification code 10058920
Conditions
Interventions
Trade Name: Sifrol
Product Name: Sifrol
Product Code: SND 919 CL2 Y
Pharmaceutical Form: Tablet
INN or Proposed INN: Pramipexole
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Co
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Women of childbearing potential (i.e. premenopausal women, or postmenopausal women less than 6 months after last menses) who do not use, during the clinical trial an adequate method of contraception such as: double barrier protection (e.g. diaphragm or condom and spermicide), intrauterine device, hormonal therapy (oral, injectable, or subcutaneous), or partner’s surgical sterilization. 2.Any women of childbearing potential not having negative pregnancy test at screening. 3.Breastfeeding women. 4.Concomitant or previous pharmacologic therapy for RLS as follows: •Any intake of dopamine agonists within 14 days prior to baseline (Visit 2) •Any intake of levodopa within 14 days prior to baseline (Visit 2) •Any intake of levodopa prior to baseline visit, if augmentation in RLS symptoms was observed •Unsuccessful prior treatment with non-ergot dopamine agonists (e.g. pramipexole, ropinorole) •Any intake of antidepressants last 6 weeks prior to baseline (Visit 2); interruption of indicated anti-depressive treatment due to study reasons is not allowed. 5.All treatment less than 14 days before baseline (Visit 2) or concomitant treatment with medication or dietary supplements, which could significantly influence RLS symptoms, e.g. dopaminergic (other than levodopa and dopamine agonists) or antidopaminergic drugs, non-selective MAO inhibitors, sympathomimetics, neuroleptics, antidepressants, hypnotics, any benzodiazepines, antiepileptics, opioids, clonidine, ferrous salts, magnesium, folic acid, vitamin B12, antihistaminics, lithium, metoclopramide. 6.Withdrawal symptoms of any medication must not be present at baseline (Visit 2). 7.Previous 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.Diagnosis of diabetes mellitus requiring insulin therapy. 10.Any of the following lab results at screening: •Patients with any clinically significant abnormalities in laboratory parameters at screening at the investigator’s discretion. •Haemoglobin (Hb) below lower limit of normal (LLN). 11.Clinically significant renal disease or calculated creatinine clearance (CrCl) lower than 30 mL/minute at screening. 12.Clinically significant hepatic disease or GPT >2 times the upper limit of normal (ULN) at screening. 13.Serum ferritin 28. 18.History of/or clinical signs of suicidal behaviour, suicide ideation or acute suicidal tendency according to the investigator’s opinion (e.g. BDI-II item 2 score =2, or item 9 score >0). 19.History of/or alcohol abuse or drug addiction within the last 2 years before screening. 20.Patients on a shift-work-schedule or who are otherwise unable to follow a regular sleep-wake cycle enabling use of study medication at times indicated. 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 wo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives are the assessment of the effects on clinical global impressions-global improvement (CGI-I responder rate), RLS (IRLS responder rate), depressive symptoms (BDI-II responder rate), pain in limbs (VAS), sleep quality and severity of RLS symptoms (RLS-6), anxiety (HADS-A), quality of life in RLS (Johns Hopkins RLS QoL questionnaire), patient global impression (PGI) and safety (AE profile) (each defined as change from baseline in comparison to placebo).;Primary end point(s): 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 (based on the IRLS scale) and on associated mood disturbances (based on IRLS item 10) and depressive symptoms (based on the Beck Depression Inventory (BDI-II), each defined as change from baseline (Visit 2) after 12 weeks of treatment (Visit 8).;Main Objective: 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 (based on the IRLS scale) and on associated mood disturbances (based on IRLS item 10) and depressive symptoms (based on the Beck Depression Inventory (BDI-II), each defined as change from baseline (Visit 2) after 12 weeks of treatment (Visit 8). | — |
Countries
Finland, Germany, Ireland, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed