JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

First night efficacy of pramipexole in restless legs syndrome and periodic leg movements

Mauro Manconi, Raffaele Ferri, Marco Zucconi, Alessandro Oldani, Maria Livia Fantini, Vincenza Castronovo, Luigi Ferini-Strambi
Sleep Medicine 2007, 8 (5): 491-7
17512780

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.

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