Riluzole in cerebellar ataxia: a randomized, double-blind, placebo-controlled pilot trial (Articolo in rivista)

Type
Label
  • Riluzole in cerebellar ataxia: a randomized, double-blind, placebo-controlled pilot trial (Articolo in rivista) (literal)
Anno
  • 2010-01-01T00:00:00+01:00 (literal)
Alternative label
  • Ristori G., Romano S., Visconti A., Cannoni S., Spadaro M., Frontali M., Pontieri F.E., Vanacore N., Salvetti M. (2010)
    Riluzole in cerebellar ataxia: a randomized, double-blind, placebo-controlled pilot trial
    in Neurology
    (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#autori
  • Ristori G., Romano S., Visconti A., Cannoni S., Spadaro M., Frontali M., Pontieri F.E., Vanacore N., Salvetti M. (literal)
Pagina inizio
  • 839 (literal)
Pagina fine
  • 845 (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#numeroVolume
  • 74 (literal)
Rivista
Note
  • ISI Web of Science (WOS) (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#affiliazioni
  • -Center for Experimental Neurological Therapies, S. Andrea Hospital, II Faculty of Medicine, Sapienza University of Rome, Via di Grottarossa 1035-1039, 00189, Rome, Italy. -Institute of Neurobiology and Molecular Medicine, National Research Council, Rome, Italy. (literal)
Titolo
  • Riluzole in cerebellar ataxia: a randomized, double-blind, placebo-controlled pilot trial (literal)
Abstract
  • BACKGROUND: The pleiotropic effects of riluzole may antagonize common mechanisms underlying chronic cerebellar ataxia, a debilitating and untreatable consequence of various diseases. METHODS: In a randomized, double-blind, placebo-controlled pilot trial, 40 patients presenting with cerebellar ataxias of different etiologies were randomly assigned to riluzole (100 mg/day) or placebo for 8 weeks. The following outcome measures were compared: proportion of patients with a decrease of at least 5 points in the International Cooperative Ataxia Rating Scale (ICARS) total score after 4 and 8 weeks compared with the baseline score; mean changes from the baseline to posttreatment ICARS (total score and subscores at 8 weeks); and occurrence of adverse events. RESULTS: Riluzole and placebo groups did not differ in baseline characteristics. The number of patients with a 5-point ICARS drop was significantly higher in the riluzole group than in the placebo group after 4 weeks (9/19 vs 1/19; odds ratio [OR] = 16.2; 95% confidence interval [CI ] 1.8-147.1) and 8 weeks (13/19 vs 1/19; OR = 39.0; 95% CI 4.2-364.2). The mean change in the riluzole group ICARS after treatment revealed a decrease (p < 0.001) in the total score (-7.05 [4.96] vs 0.16 [2.65]) and major subscores (-2.11 [2.75] vs 0.68 [1.94] for static function, -4.11 [2.96] vs 0.37 [2.0] for kinetic function, and -0.74 [0.81] vs 0.05 [0.40] for dysarthria). Sporadic, mild adverse events occurred. CONCLUSIONS: These findings indicate the potential effectiveness of riluzole as symptomatic therapy in diverse forms of cerebellar ataxia. Classification of evidence: This study provides Class I evidence that riluzole reduces, by at least 5 points, the ICARS score in patients with a wide range of disorders that cause cerebellar ataxia (risk difference 63.2%, 95% CI 33.5%-79.9%). (literal)
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