Idiopathic Restless legs Syndrome
Conditions
Interventions
Trade Name: Lyrica
Product Name: Pregabalin (Lyrica
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pregabalin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
INSTITUTO DE ESTUDIOS DEL SISTEMA NERVIOSO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Idiopathic restless legs syndrome (RLS) with a history (if currently controlled on medication) or presence of all four clinical manifestations 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 movements, 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.) - A history (if currently controlled on medication) or the presence of RLS symptoms interfering with sleep onset or maintenance on 4 or more nights per week for at least 6 months. - Subjects should have an IRLS total score at baseline of =15 points. - If a polysomnographic stdy had been performed before entering the study, a Periodic Leg Movement during Sleep (PLMS) index > 10. 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: - Any forms of secondary RLS. - Current diagnosis of (clinically relevant) concomitant conditions that may confound assessments as to the judgement of the investigator, for example, muscle fasciculation and painful leg and moving toes syndrome. - Subject has other severe central nervous diseases like Parkinson’s disease, dementia, progressive supranuclear paresia, multisystem atrophy, Huntington Chorea, amyotrophic lateral sclerosis, or Alzheimer’s disease. - Failure to respond to gabapentin in the previous medical history. - Subject has a known hypersensivity to any components of the trial medication or similar drugs. - Previous stable, long-term treatment with dopaminergic medication - Serum ferritin below 18mg/L. - History or presence at the screening or baseline visits, of a severe sleep disorder that may confound assessments (i.e., Apnea/Hypopnea Index greater than 20). - Use of drugs likely to influence sleep architecture or motor manifestations during sleep prior to the baseline visit (B1) without an appropriate washout period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the therapeutic response of motor and sensorial symptoms in idiopathic RLS patients to a 12 week treatment period with pregabalin, by means of the International Restless Legs Scale (IRLS);Secondary Objective: - To determine the therapeutic response of Periodic Leg Movement (sleep) Index (PLMS-index) to pregabalin - To assess the impact of pregabalin on subjective perception of sleep as well as on polysomnographic assessment of sleep. - To assess the safety and tolerability of pregabalin versus placebo in patients with RLS - To evaluate the impact of pregabalin on Quality of Life in RLS. - To evaluate the effects of pregabalin on self perceived anxiety and mood in patients with RLS, through STAI scale. ;Primary end point(s): - International Restless Legs Study Group Rating Scale (IRLS). | — |
Countries
Spain
Outcome results
None listed