AIMS: 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. CONCLUSION: The dose of 50mg once a day was chosen for the clinical trial evaluating the efficacy of riluzole in SMA patients.
AIMS: 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 ALSpatients 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. CONCLUSION: The dose of 50mg once a day was chosen for the clinical trial evaluating the efficacy of riluzole in SMA patients.
Authors: T L Munsat; L Skerry; B Korf; B Pober; Y Schapira; G G Gascon; S M al-Rajeh; V Dubowitz; K Davies; L M Brzustowicz Journal: Neurology Date: 1990-12 Impact factor: 9.910
Authors: A Le Liboux; P Lefebvre; Y Le Roux; P Truffinet; M Aubeneau; S Kirkesseli; G Montay Journal: J Clin Pharmacol Date: 1997-09 Impact factor: 3.126
Authors: G J Groeneveld; H J M Van Kan; S Kalmijn; J H Veldink; H-J Guchelaar; J H J Wokke; L H Van den Berg Journal: Neurology Date: 2003-10-28 Impact factor: 9.910
Authors: Renske I Wadman; W Ludo van der Pol; Wendy Mj Bosboom; Fay-Lynn Asselman; Leonard H van den Berg; Susan T Iannaccone; Alexander Fje Vrancken Journal: Cochrane Database Syst Rev Date: 2020-01-06
Authors: Renske I Wadman; W Ludo van der Pol; Wendy Mj Bosboom; Fay-Lynn Asselman; Leonard H van den Berg; Susan T Iannaccone; Alexander Fje Vrancken Journal: Cochrane Database Syst Rev Date: 2019-12-11