Lyrica Trial for Adolescent Fibromyalgia Fails, but Offers Other Positive Findings

Lyrica Trial for Adolescent Fibromyalgia Fails, but Offers Other Positive Findings
Two Phase 4 clinical trials of Lyrica (pregabalin) in adolescent fibromyalgia patients failed to statistically improve mean pain scores, but showed good effects on a number of other measurements, suggesting that adolescents with fibromyalgia might benefit from this drug treatment. The report, "Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study," published by researchers from the University of Cincinnati College of Medicine in the journal of Pediatric Rheumatology, suggests that more research is necessary to develop a drug treatment suitable for this age group of patients. Lyrica is approved both in the U.S. and Europe for adults with fibromyalgia, but adolescents suffering from the condition are left without approved treatments. The clinical trials, sponsored by Pfizer, included adolescents ages 12 to 17 who were recruited to study centers across the U.S., India, Taiwan, and the Czech Republic. The first trial (NCT01020474) explored how 15 weeks of treatment affected 80 youngsters randomized to receive either Lyrica or a placebo, and was followed by a six-month follow-up study (NCT01020526) involving participants from the first study. In the follow-up trial, all participants received Lyrica, as the trial intended to study treatment safety. The dose for all participants was optimized a
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