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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  1. J. Kanter says:

    Imagine being a child and later, an adolescent who complained of pain. Especially back pain. Next imagine seeing adults roll their eyes and say, “You’re too young for back pain.” Later, hearing said to another adult (in front of you), “She just wants attention.” Later, being punished for talking about it. I know this has nothing to do with your study, but now I’m broke and alone with no future ahead, despite having a PhD in health psychology. After a long marriage that split up because we had to move away for his new ivory tower position, I can’t find work because I’m too old! Can anyone help me? Or should I end up homeless and living in a cardboard box?

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