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 - ND
- Conditions
- Restless Legs Syndrome, RLSMedDRA version: 6.1Level: PTClassification code 10058920
- Registration Number
- EUCTR2005-006128-13-IT
- Lead Sponsor
- BOEHRINGER ING.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 520
-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. 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.
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
-Women of child-bearing potential who do not use, during the clinical trial an adequate method of contraception e.g. mechanical and pharmacological therapy , or partner s surgical sterilization. -Any women of child-bearing potential not having negative pregnancy test at screening. -Breastfeeding women. -Concomitant or previous pharmacologic therapy for RLS as follows Any intake of dopamine agonists and 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, ropinirole 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. -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. -Withdrawal symptoms of any medication must not be present at baseline Visit 2 . -Previous 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. -Diagnosis of diabetes mellitus requiring insulin therapy. -Any of the following laboratory 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 -Clinically significant renal disease or calculated creatinine clearance CrCl lower than 30 mL/minute at screening. -Clinically significant hepatic disease or GPT 2 times the upper limit of normal ULN 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 other than RLS-related , such as Rapid Eye Movement REM sleep disorder, narcolepsy or sleep apnoea syndrome. -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 investigator s opinion e.g. BDI-II item 2 score 2, or item 9 score 0 . -History of/or alcohol abuse or drug addiction within the last 2 years before screening. -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. -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 would interfere with the evaluation of the results or constitute a health hazard for the patient according to SPC SPC Sifrol .
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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 ;Secondary Objective: 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 endpoint is the change from baseline after 12 weeks of treatment in IRLS total score, IRLS item 10 score and BDI-II total score.
- Secondary Outcome Measures
Name Time Method