title: Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study.
abstract: BACKGROUND
  Fibromyalgia (FM) is a common pain condition characterized by widespread musculoskeletal pain and tenderness. Pregabalin is an approved treatment for adults in the United States, but there are no approved treatments for adolescents with FM.
  
  
  METHODS
  This was a 15-week, randomized, double-blind, placebo-controlled study and 6-month open-label safety trial of flexible-dose pregabalin (75-450 mg/day) for the treatment of adolescents (12-17 years) with FM. Primary outcome was change in mean pain score at endpoint (scored from 0-10, with 24-h recall). Secondary outcomes included global assessments and measures of pain, sleep, and FM impact.
  
  
  RESULTS
  A total of 107 subjects were randomized to treatment (54 pregabalin, 53 placebo) and 80 completed the study (44 pregabalin, 36 placebo). Improvement in mean pain score at endpoint with pregabalin versus placebo was not statistically significant, treatment difference (95 % CI), -0.66 (-1.51, 0.18), P = 0.121. There were significant improvements with pregabalin versus placebo in secondary outcomes of change in pain score by week (P < 0.05 for 10 of 15 weeks); change in pain score at week 15 (1-week recall), treatment difference (95 % CI), -0.87 (-1.68, -0.05), P = 0.037; and patient global impression of change, 53.1 % versus 29.5 % very much or much improved (P = 0.013). Trends toward improvement with pregabalin in other secondary outcomes measuring pain, sleep, and FM impact were not significant. Safety was consistent with the known profile of pregabalin in adults with FM.
  
  
  CONCLUSIONS
  Pregabalin did not significantly improve the mean pain score in adolescents with FM. There were significant improvements in secondary outcomes measuring pain and impression of change.
  
  
  BACKGROUND
  NCT01020474 ; NCT01020526 .
authors.affiliation: University of Cincinnati College of Medicine, 260 Stetson Street, Suite 3200, Cincinnati, OH, 45219, USA. Lesley.Arnold@uc.edu.
authors.forename: Lesley M
authors.identifier: http://orcid.org/0000-0003-0393-9948
authors.initials: LM
authors.lastname: Arnold
authors.affiliation: University of Louisville School of Medicine, Kosair Children's Hospital, Louisville, KY, USA.
authors.forename: Kenneth N
authors.initials: KN
authors.lastname: Schikler
authors.affiliation: Bateman Horne Center, Salt Lake City, UT, USA.
authors.forename: Lucinda
authors.initials: L
authors.lastname: Bateman
authors.affiliation: Pfizer, Groton, CT, USA.
authors.forename: Tahira
authors.initials: T
authors.lastname: Khan
authors.affiliation: Pfizer, Groton, CT, USA.
authors.forename: Lynne
authors.initials: L
authors.lastname: Pauer
authors.affiliation: Pfizer, New York, NY, USA.
authors.forename: Pritha
authors.initials: P
authors.lastname: Bhadra-Brown
authors.affiliation: Pfizer, New York, NY, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Clair
authors.affiliation: Pfizer, Groton, CT, USA.
authors.forename: Marci L
authors.initials: ML
authors.lastname: Chew
authors.affiliation: Pfizer, Groton, CT, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Scavone
mesh_terms: D000293:Adolescent; D000700:Analgesics / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D005356:Fibromyalgia / Q000188:drug therapy*; D006801:Humans; D008297:Male; D010147:Pain Measurement; D000069583:Pregabalin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D000069583:Pregabalin
keywords: Clinical trial; Juvenile fibromyalgia; Pain; Pregabalin