New Spinal Muscular Atrophy Study Findings Recently Were Published by C. Abbara and Co-Researchers.(Report)
Clinical Trials Week April 25, 2011 According to recent research from Angers, France, “center dot Spinal muscular atrophy (SMA) is a neuromuscular disorder of childhood. center dot Riluzole is an anti-excitatory agent recommended for the treatment of amyotrophic lateral sclerosis (ALS). center dot Riluzole pharmacokinetics are well documented in patients with ALS. WHAT THIS ADDS center dot Riluzole pharmacokinetics have never documented in patients with SMA. center dot This study showed that the administration of 50 mg riluzole once a day to patients with SMA leads to total riluzole daily exposure comparable with that obtained after the administration of 50 mg twice a day in healthy volunteers or ALS patients.” “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 50 mg riluzole orally for 5 days. Riluzole plasma concentrations were determined from samples obtained at day 5. The pharmacokinetic analysis demonstrated that a dose of 50 mg once a day was sufficient to obtain a daily total exposure [AUC(0,24 h) = 2257 ng ml-1 h] which was comparable with results obtained in adult healthy volunteers or ALS patients in whom a dose of 50 mg twice a day is recommended. The pharmacokinetic simulation demonstrated that the administration of 50 mg twice a day could result in higher concentrations, hence reduced safety margin,” wrote C. Abbara and colleagues (see also Spinal Muscular Atrophy). this web site spinal muscular atrophy go to website spinal muscular atrophy
The researchers concluded: “The dose of 50 mg once a day was chosen for the clinical trial evaluating the efficacy of riluzole in SMA patients.” Abbara and colleagues published their study in British Journal of Clinical Pharmacology (Riluzole pharmacokinetics in young patients with spinal muscular atrophy. British Journal of Clinical Pharmacology, 2011;71(3):403-410).
For additional information, contact C. Abbara, University of Angers, UFR Medical, 4 Rue Larrey, F-49000 Angers, FRANCE.
Publisher contact information for the British Journal of Clinical Pharmacology is: Wiley-Blackwell, Commerce Place, 350 Main St., Malden 02148, MA, USA.
