title: The MOBILE Study-A Phase IIa Enriched Enrollment Randomized Withdrawal Trial to Assess the Analgesic Efficacy and Safety of ASP8477, a Fatty Acid Amide Hydrolase Inhibitor, in Patients with Peripheral Neuropathic Pain.
abstract: OBJECTIVE
  To evaluate the analgesic efficacy and safety of ASP8477 in patients with peripheral neuropathic pain (PNP).
  
  
  METHODS
  Enriched enrollment randomized withdrawal.
  
  
  METHODS
  Centers in Poland (four), Czech Republic (six), and the United Kingdom (two).
  
  
  METHODS
  Patients aged 18 years or older with PNP resulting from painful diabetic peripheral neuropathy or postherpetic neuralgia.
  
  
  METHODS
  A four-week screening period followed by a single-blind period (six-day dose titration and three-week maintenance period with ASP8477 [20/30 mg BID]). Treatment responders (defined as a ≥30% decrease in the mean average daily pain intensity during the last three days of the single-blind period) were stratified by disease and randomized to receive placebo or continue ASP8477 during a three-week, double-blind, randomized withdrawal period. The primary end point was change in mean 24-hour average numeric pain rating scale (NPRS) from baseline to end of double-blind period.
  
  
  RESULTS
  Among 132 patients who enrolled, 116 entered the single-blind period and 63 (ASP8477, N = 31; placebo, N = 32) completed the double-blind period. There was no difference in mean 24-hour average NPRS score (P = 0.644) or in time-to-treatment failure (P = 0.485) between ASP8477 and placebo. During the single-blind period, 57.8% of patients were treatment responders. ASP8477 was well tolerated. During the single-blind period, 22% of patients experienced at least one treatment-related adverse event (TEAE); during the double-blind period, 8% in the ASP8477 arm and 18% in the placebo arm experienced at least one TEAE.
  
  
  CONCLUSIONS
  ASP8477 was well tolerated in patients with PNP; however, ASP8477 did not demonstrate a significant treatment difference compared with placebo.
authors.affiliation: Astellas Pharma Europe B.V., Leiden, the Netherlands.
authors.forename: Daniel
authors.initials: D
authors.lastname: Bradford
authors.affiliation: Astellas Pharma Europe B.V., Leiden, the Netherlands.
authors.forename: Anjali
authors.initials: A
authors.lastname: Stirling
authors.affiliation: Astellas Pharma Europe B.V., Leiden, the Netherlands.
authors.forename: Etienne
authors.initials: E
authors.lastname: Ernault
authors.affiliation: Astellas Pharma Global Development, Northbrook, Illinois, USA.
authors.forename: Maggie
authors.initials: M
authors.lastname: Liosatos
authors.affiliation: Astellas Pharma Global Development, Northbrook, Illinois, USA.
authors.forename: Katherine
authors.initials: K
authors.lastname: Tracy
authors.affiliation: Astellas Pharma Global Development, Northbrook, Illinois, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Moseley
authors.affiliation: Astellas Pharma Global Development, Northbrook, Illinois, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Blahunka
authors.affiliation: Astellas Pharma Global Development, Northbrook, Illinois, USA.
authors.forename: Mike D
authors.initials: MD
authors.lastname: Smith
mesh_terms: D000328:Adult; D000368:Aged; D000581:Amidohydrolases / Q000037:antagonists & inhibitors*; D000700:Analgesics / Q000627:therapeutic use*; D003929:Diabetic Neuropathies / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D051474:Neuralgia, Postherpetic / Q000188:drug therapy*; D059408:Pain Management / Q000379:methods*; D010523:Peripheral Nervous System Diseases / Q000150:complications; D016037:Single-Blind Method; D016896:Treatment Outcome; D000099252:Fatty Acid Amide Hydrolases
chemical_list: D000581:Amidohydrolases; D000700:Analgesics; D000099252:Fatty Acid Amide Hydrolases
keywords: ASP8477; Enriched Enrollment Randomized Withdrawal; Fatty Acid Amide Hydrolase Inhibitor; Painful Diabetic Peripheral Neuropathy; Peripheral Neuropathic Pain; Postherpetic Neuralgia