First night efficacy of pramipexole in restless legs syndrome and periodic leg movements.
OBJECTIVE
Restless legs syndrome (RLS) seems to improve immediately after a single dose of dopamine-agonists (DA). The aim of the present study was to investigate the acute effects of a low standard dose of pramipexole in RLS drug-naïve patients.


METHODS
A single-blind placebo-controlled study in 32 consecutive idiopathic RLS de-novo patients was carried out. Patients who met the standard criteria for RLS, with a PLMS index greater than 10 as well as an RLS rating scale score greater than 20 underwent clinical and neurophysiological evaluation, hematological screening and two consecutive full-night polysomnographies. On the second night, all patients received 0.25mg of pramipexole or placebo at 9:00 p.m. Acute symptom response was assessed by a visual analogical scale (VAS).


RESULTS
Eighteen patients received pramipexole and 14 patients received placebo. Compared to placebo, the single low dose (0.25mg) of pramipexole significantly improved RLS symptoms (VAS: from 7.4+/-1.68 to 1.3+/-1.62, p<0.00001) and strongly reduced PLMS index (from 45.8+/-33.56 to 9.4+/-11.40, p<0.0002). A significant increase in the percentage of stage 2 non-rapid eye movement (NREM) sleep was also observed in the pramipexole group (from 38.7+/-10.50 to 50.6+/-12.13, p<0.02).


CONCLUSIONS
A low dose of pramipexole was effective in treatment-naïve patients with RLS from the first night of administration. These results support a direct involvement of the dopaminergic system in RLS pathogenesis and might have important implications for a possible future pramipexole administration on-demand, as well as for a pharmacological test to confirm diagnosis in clinically complex cases.
Manconi
Mauro
M
Sleep Disorders Center, Department of Neurology, Scientific Institute and University Ospedale San Raffaele, Vita-Salute University, Milan, Italy. manconi.mauro@hsr.it
Ferri
Raffaele
R
Zucconi
Marco
M
Oldani
Alessandro
A
Fantini
Maria Livia
ML
Castronovo
Vincenza
V
Ferini-Strambi
Luigi
L
D000328:Adult; D000368:Aged; D052160:Benzothiazoles / Q000008:administration & dosage*; D018491:Dopamine Agonists / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017286:Polysomnography / Q000379:methods; D000077487:Pramipexole; D012148:Restless Legs Syndrome / Q000188:drug therapy*; D012720:Severity of Illness Index; D016037:Single-Blind Method; D012894:Sleep Stages / Q000187:drug effects; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D052160:Benzothiazoles; D018491:Dopamine Agonists; D000077487:Pramipexole