title: Riluzole pharmacokinetics in young patients with spinal muscular atrophy.
abstract: OBJECTIVE
  The objective of the present study was to assess the pharmacokinetics of riluzole in patients with spinal muscular atrophy (SMA).
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  The dose of 50mg once a day was chosen for the clinical trial evaluating the efficacy of riluzole in SMA patients.
authors.affiliation: Université d'Angers, UFR médecine, Angers cedex, F-49045 CHU d'Angers, Service Pharmacologie-Toxicologie, Angers cedex 09, France.
authors.forename: Chadi
authors.initials: C
authors.lastname: Abbara
authors.forename: Brigitte
authors.initials: B
authors.lastname: Estournet
authors.forename: Lucette
authors.initials: L
authors.lastname: Lacomblez
authors.forename: Benedicte
authors.initials: B
authors.lastname: Lelièvre
authors.forename: Amal
authors.initials: A
authors.lastname: Ouslimani
authors.forename: Blandine
authors.initials: B
authors.lastname: Lehmann
authors.forename: Louis
authors.initials: L
authors.lastname: Viollet
authors.forename: Annie
authors.initials: A
authors.lastname: Barois
authors.forename: Bertrand
authors.initials: B
authors.lastname: Diquet
mesh_terms: D000293:Adolescent; D019540:Area Under Curve; D002648:Child; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008962:Models, Theoretical; D009134:Muscular Atrophy, Spinal / Q000188:drug therapy*; D018696:Neuroprotective Agents / Q000008:administration & dosage*; D019782:Riluzole / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018696:Neuroprotective Agents; D019782:Riluzole