The purpose of this study was to determine whether duloxetine is safe and effective in the treatment of adolescents with Juvenile Primary Fibromyalgia Syndrome (JPFS).
JPFS is a musculoskeletal pain syndrome characterized by multiple tender points, fatigue, and sleep problems in children and teenagers. Girls are more likely than boys to be diagnosed with JFMS. Up to 75 percent have a family member with a diagnosis of fibromyalgia. JPFS is diagnosed in 25 to 40% of children with musculoskeletal pain syndromes. Duloxetine, also known as Cymbalta, Ariclaim, Xeristar, Yentreve, Duzela, is a long-acting medication used to treat depression or generalized anxiety disorder or the pain of diabetic neuropathy or fibromyalgia, in adults, or ongoing bone or muscle pain.
The trial consisted of two distinct study periods. A blinded treatment period of 13 weeks and an open label extension period of 26 weeks.
184 participants aged from 13 to 17 participated in this randomized study.
The study's primary end point was the mean change on the Brief Pain Inventory (BPI) average pain severity rating from baseline to week 13. Secondary end points included BPI-Modified Short Form: Adolescent Version severity and interference, treatment response (30% and 50% reductions in BPI average pain severity), and scores on the Pediatric Pain Questionnaire, Clinical Global Impression of Severity: Overall and Mental Illness scales, Functional Disability Inventory: child and parent version scales, Children's Depression Inventory, and the Multidimensional Anxiety Scale for Children, as well as safety and tolerability. Of the 184 participants, 149 (80.98%) completed the 13-week treatment. CPA
The results of this study indicate that Duloxetine may not be effective in treating JPFS when compared to a placebo. No new safety concerns relating to Duloxetine were found.