Safety and efficacy of pregabalin in adolescents with fibromyalgia: A randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study
Journal
Pediatric Rheumatology
Journal Volume
14
Journal Issue
1
Pages
46
Date Issued
2016
Author(s)
Arnold L.M.
Schikler K.N.
Bateman L.
Khan T.
Pauer L.
Bhadra-Brown P.
Clair A.
Chew M.L.
Scavone J.
Alario A.
Babhulkar S.S.
Berenguer R.
Freeman P.
Gold J.
Goodman S.
Jarosova H.
Lee W.
Liss J.
Lvovich S.
Maiquez A.
Morcos N.
Nellikunja S.
Passo M.
Schanberg L.
Sharma V.P.
Spencer C.
Toth M.
Veeravalli S.C.M.
on behalf of the Pregabalin Adolescent Fibromyalgia Study Group
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. Conclusion: 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. Trial registrations:NCT01020474 ; NCT01020526. ? 2016 The Author(s).
Subjects
Clinical trial; Juvenile fibromyalgia; Pain; Pregabalin
SDGs
Other Subjects
placebo; pregabalin; analgesic agent; pregabalin; abdominal pain; adolescent; appendicitis; arthralgia; Article; attention disturbance; backache; child; cholelithiasis; controlled study; dizziness; double blind procedure; drug efficacy; drug safety; drug withdrawal; fatigue; female; fever; fibromyalgia; Fibromyalgia Impact Questionnaire; headache; human; joint instability; limb pain; major clinical study; major depression; male; mental instability; migraine; multicenter study; musculoskeletal disease assessment; nausea; open study; oropharynx pain; pain; pain assessment; parallel design; patient global impression of change; pneumonia; post hoc analysis; priority journal; randomized controlled trial; school child; side effect; sleep quality; somnolence; sprain; upper abdominal pain; upper respiratory tract infection; vomiting; weight gain; fibromyalgia; pain measurement; treatment outcome; Adolescent; Analgesics; Child; Double-Blind Method; Female; Fibromyalgia; Humans; Male; Pain Measurement; Pregabalin; Treatment Outcome
Publisher
BioMed Central Ltd.
Type
journal article