Restless Legs Syndrome MedDRA version: 9.1 Level: PT Classification code 10058920 Term: Restless legs syndrome
Conditions
Interventions
Trade Name: SIFROL
Product Code: SND 919 CL2 Y
Pharmaceutical Form: Tablet
INN or Proposed INN: Pramipexole
Current Sponsor code: SND 919 CL2 Y
Concentration unit: mg milligram(s)
Concentration type:
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 18-85 years 3. 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). 4. RLS symptoms present at least 2 to 3 days per week during the last 3 months prior to baseline (Visit 2) 5. IRLS total score >15 at baseline (Visit 2) 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 child-bearing 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 woman of child-bearing potential not having a negative pregnancy test at screening 3. Breastfeeding women 4. Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets 5. Diagnosis of augmentation under previous pharmacological RLS treatment 6. Concomitant or previous pharmacologic therapy 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) • Unsuccessful prior treatment with non-ergot dopamine agonists (e.g. pramipexole, ropinirole) 7. 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, hypnotics, any benzodiazepines, antiepileptics, opioids, ferrous salts. 8. Withdrawal symptoms of any medication present at baseline (Visit 2) 9. Patients receiving antidepressants with any known changes and instabilities in this medication during the last 4 weeks before baseline (Visit 2). (Patients receiving antidepressants for any indication can only be included in the trial if dose and type of antidepressant medication has been unchanged and stable for at least 4 weeks before baseline and is planned to stay unchanged and stable throughout the trial.) 10. History of (during the last 2 years before baseline)/ or presence of a major depressive or bipolar disorder or any psychotic disorder, mental disorders or any present Axis I psychiatric disorder according to DSM IV requiring any therapy 11. History of/or clinical signs of suicidal behaviour, suicide ideation or acute suicidal tendency according to the investigator’s opinion 12. Clinically significant renal disease or calculated creatinine clearance (CrCl) lower than 30 mL/minute at screening (calculation according to the formula of Cockcroft&Gault [R96-0690] see 5.2 laboratory tests) 13. Serum ferritin = 30 ng/mL at screening 14. Patients with any other clinically significant abnormalities in laboratory parameters at screening at the investigator’s discretion 15. Presence of a clinically relevant sleep disorder other than RLS-related 16. Diagnosis of diabetic polyneuropathy 17. Diagnosis of Parkinson’s disease or syndrome 18. History of/or presence of malignant melanoma 19. History of/or presence of a clinically relevant ophthalmopathy other than ametropia or presbyopia (e.g. glaucoma, macula degeneration, retinopathy) 20. History of/or presence of alcohol abuse or drug addiction within the last 2 years before screening 21. 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 [R06-2803, R06-2767] and/or in the opinion of the investigator 22. Patients on a shift-work-schedule who are unable to follow a regular sleep-wake cycle enabling use of study med
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the current study will be the evaluation of long-term efficacy of a 26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless Legs Syndrome in comparison to placebo. ;Primary end point(s): The primary endpoint will be the change from baseline after 26 weeks of treatment in the total score of the International Restless Legs Syndrome Study Group Rating Scale (IRLS) under treatment with pramipexole in comparison to placebo.;Secondary Objective: The key secondary objectives are to assess the effects on clinical global impressions - global improvement (based on CGI-I responder rate) and on RLS (based on IRLS responder rate) for 26 weeks under pramipexole in comparison to placebo. Further secondary objectives are to investigate the incidence and severity of augmentation and rebound and to assess the effects on patient global impression (based on PGI responder rate), on RLS symptoms (based on the RLS-6 scales), on associated mood disturbance (based on item 10 of the IRLS), on pain in limbs (based on a visual analogue scale), on quality of life in RLS (based on Johns Hopkins RLS-QoL), on general quality of life (SF-36) and on safety (based on AE profile) of pramipexole in comparison to placebo. | — |
Countries
Austria, Finland, Germany, Greece, Ireland, Spain, United Kingdom
Outcome results
None listed