A randomized, double-blind, placebo-controlled trial of pramipexole, a dopamine agonist, in patients with fibromyalgia receiving concomitant medications

Objective. To assess the efficacy and safety of pramipexole, a dopamine 3 receptor agonist, in patients with fibromyalgia. Methods. In this 14-week, single-center, double-blind, placebo-controlled, parallel-group, escalating-dose trial, 60 patients with fibromyalgia were random-ized 2:1 (pramipexole:placebo) to receive 4.5 mg of pramipexole or placebo orally every evening. The pri-mary outcome was improvement in the pain score (10-cm visual analog scale [VAS]) at 14 weeks. Second-ary outcome measures were the Fibromyalgia Impact Questionnaire (FIQ), the Multidimensional Health As-sessment Questionnaire (MDHAQ), the pain improve-ment scale, the tender point score, the 17-question Hamilton Depression Inventory (HAM-d), and the Bec