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 preg

SUBMITTER: Arnold LM 

PROVIDER: S-EPMC4967327 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature