Restless legs syndrome MedDRA version: 18.0 Level: PT Classification code 10058920 Term: Restless legs syndrome System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Targin ® 5mg/2,5 mg
Pharmaceutical Form: Prolonged-release tablet
Trade Name: Targin ® 10mg/5 mg
Product Name: oxycodone/naloxone
Pharmaceutical Form: Prolonged-release tablet
Trade Name
Sponsors
Fondazione Neureca Onlus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent; • Subject understands the investigational nature of the trial and is willing and able to comply with the trial requirements; • Subject is able to take the trial tablets correctly and consistently; • Subject is male or female, and is =18 and = 75 years of age; • Subject meets the diagnosis of idiopathic RLS based on the 4 essential clinical features according to the IRLSSG (Allen et al, 2003): o An urge to move legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs (the urge to move can be present without uncomfortable sensations. Arms or other body parts can also be affected.); o The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting; o 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; o 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.); • Subject is de novo (ie, had no previous treatment for RLS) or has been without dopaminergic treatment for at least one week; • At Screening visit (Visit 1), subject has a score of =15 on the IRLS Rating Scale (indicating moderate to severe RLS). • At Screening visit (Visit 1), subject scores =4 points on the CGI Severity assessment (indicating mildly ill). • At Baseline (Visit 2), subject scores =15 PLM/h on the PLMI based on PSG (recorded during the second night) as assessed by the investigator. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Subject has secondary RLS (e.g. due to renal insufficiency [uremia], iron deficiency anemia, or rheumatoid arthritis); • Subject has secondary RLS associated with previous (within 3 weeks) or concomitant therapy with dopamine D2 receptor antagonists, butyrophenones, metoclopramide, atypical antipsychotics (eg, olanzapine), tri-and tetra-cyclic antidepressants, mianserine, lithium or H2-blockers (eg, cimetidine), or due to withdrawal from drugs such as anticonvulsants, benzodiazepines, barbiturates, and other hypnotics; • Subject has a history of sleep disturbances like sleep apnea syndrome (including obstructive sleep apnoea), narcolepsy, sleep attacks/sudden onset of sleep, or myoclonus epilepsy either observed during PSG (local PSG evaluations) or evidenced by subject history; • Subject has additional clinically relevant concomitant diseases such as attention deficit hyperactivity disorder, polyneuropathy, akathisia, muscle fasciculation, painful legs and moving toes, or radiculopathy; • Subject has other central nervous system diseases such as Parkinson's disease, dementia, progressive supranuclear palsy, multisystem atrophy, Huntington's Chorea, amyotrophic lateral sclerosis, or Alzheimer's disease; • Subject has a prior history of psychotic episodes; • Subject has a history of chronic alcohol or drug abuse within the last 12 months; • Subject has any medical or psychiatric condition, which in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this trial; • Subject has clinically relevant cardiac dysfunction and/or arrhythmias (e.g. suspected conduction system dysregulations, second or third degree AV block, complete left or right bundle branch block, sick-sinus-syndrome, New York Heart Association Class III or IV congestive heart failure, or has had a myocardial infarction within 12 months prior to Screening [Visit 1]); • Subject has clinically relevant venous or arterial peripheral vascular disease; • Subject has clinically relevant renal dysfunction (serum creatinine >2.0mg/dL); • Subject has a malignant neoplastic disease; • Subject has any contraindication to OXN: o hypersensitivity to oxycodone, naloxone or lactose, o situations where opioids are contraindicated (e.g. patients with severe respiratory o depression with hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma or non-opioid induced paralytic ileus), o patients with moderate or severe hepatic impairment; • Subject has a known hypersensitivity to pramipexole; • Subject is currently receiving treatment with any of the following drug classes: neuroleptics, hypnotics, antidepressants, anxiolytic drugs, anticonvulsive therapy, budipine, dopamine antagonist anti-emetics (except domperidone), opioids, benzodiazepines, monoamine oxidase (MAO) inhibitors, catechol-O-methyl-transferase (COMT) inhibitors, sedative antihistamines, psycho stimulates, or amphetamines. If subject has received such therapy, a washout period of at least 14 days prior to Baseline (Visit 2) is required before starting treatment in this trial; • Subject has had previous treatment with dopamine agonists within a period of 21 days prior to Baseline (Visit 2), or L-dopa within 7 days prior to Baseline (Visit 2); • Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, 2 years postmenopausal, or does not consistently use 2 combi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare efficacy and safety of OXN-PR (Oxycodone/Naloxone prolonged release tablets, Targin®) and pramipexole (PRA) in subjects with idiopathic Restless Legs Syndrome (RLS) The primary objectives of the study will be the comparison between the study medications based on Sleep Efficiency as measured by PSG.;Secondary Objective: The secondary objectives will be to compare the the effects of the two treatments on the Periodic Limb Movements Index (PLMI) as measured by PSG and to compare the effects of the two treatments on a number of objective sleep quality indicators and subjective ratings .The following secondary variables will be measured: • Sleep latency • Total Sleep Time • IRLS (International Restless Legs Syndrome Study Group Rating scale) • Pittsburg Sleep Quality Index • Epworth Sleepiness Scale • CGI Improvement • RLS quality of life ;Primary end point(s): The primary endpoints is the difference between treatments in Sleep Efficiency, as measured by PSG. Sleep Efficiency is the ratio of time spent asleep (total sleep time) to the amount of time spent in bed. An increase in Sleep efficiency at the end of the treatment period with respect to baseline is expected.;Timepoint(s) of evaluation of this end point: End of the treatment period (nights 15 -16) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The primary secondary endpoint is the difference between treatments in PLMI (Periodic Limb Movements Index), as measured by PSG at the end of the treatment period, with respect to baseline. The following secondary variables will be measured: • Sleep latency (onset of sleep from time the lights are turned off) • Total Sleep Time (TST) • PLMS Awakening Index (PLMSAWI: number of awakenings with PLMs during sleep/TST) • Total time in sleep stages (absolute and relative) • IRLS (Information Restless Legs Syndrome) rating scale • CGI (Clinical Global Improvement) • Pittsburg Sleep Quality Index (PSQI) • Epworth Sleepiness Scale (ESS) In addition, the RLS Quality of Life (RLS-QoL) questionnaire will be used to measure changes in quality of life. ;Timepoint(s) of evaluation of this end point: End of the treatment period (morning of day 17) | — |
Countries
Italy
Contacts
Public Contactinfo@mcr-med.com
Mediolanum Cardio Research
Outcome results
None listed