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Br J Clin Pharmacol. 2011 Mar;71(3):403-10. doi: 10.1111/j.1365-2125.2010.03843.x.

Riluzole pharmacokinetics in young patients with spinal muscular atrophy.

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  • 1Université d'Angers, UFR médecine, Angers cedex, F-49045 CHU d'Angers, Service Pharmacologie-Toxicologie, Angers cedex 09, France.



The objective of the present study was to assess the pharmacokinetics of riluzole in patients with spinal muscular atrophy (SMA).


Fourteen patients were enrolled in an open-label, nonrandomized and repeat-dose pharmacokinetic study. All participants were assigned to receive 50mg riluzole orally for 5 days. Riluzole plasma concentrations were determined from samples obtained at day 5.


The pharmacokinetic analysis demonstrated that a dose of 50mg once a day was sufficient to obtain a daily total exposure [AUC(0,24h)=2257ng ml(-1) h] which was comparable with results obtained in adult healthy volunteers or ALS patients in whom a dose of 50mg twice a day is recommended. The pharmacokinetic simulation demonstrated that the administration of 50mg twice a day could result in higher concentrations, hence reduced safety margin.


The dose of 50mg once a day was chosen for the clinical trial evaluating the efficacy of riluzole in SMA patients.

© 2011 The Authors. British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society.

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