Comparative Study of Oxycodone/Naloxone or Pramipexole for the Treatment of Restless Legs Syndrome on sleep quality recorded by polysomnography

Phase 1

• Conditions: Restless legs syndrome; MedDRA version: 18.0Level: PTClassification code 10058920Term: Restless legs syndromeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-000140-15-IT
• Lead Sponsor: Fondazione Neureca Onlus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-30
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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):
oAn 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.);
oThe urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting;
oThe 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;
oThe 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

•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:
ohypersensitivity to oxycodone, naloxone or lactose,
osituations where opioids are contraindicated (e.g. patients with severe respiratory
odepression with hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma or non-opioid induced paralytic ileus),
opatients 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified