Adolescent Fibromyalgia Study

Summary

This study will compare pregabalin with placebo over a 15 week period in adolescents with fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.

Timeline

Start

2010-05

Primary completion

2014-12

Completion

2014-12

Outcome

Missed primary endpoint

paper 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. PMID 27475753 ↗

Publications

• Arnold LM, Schikler KN, Bateman L, Khan T, Pauer L, Bhadra-Brown P, Clair A, Chew ML, Scavone J; Pregabalin Adolescent Fibromyalgia Study Group. Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study. Pediatr Rheumatol Online J. 2016 Jul 30;14(1):46. doi: 10.1186/s12969-016-0106-4.

Drugs

Indications