Value through Innovation27 July 2016

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Clinical Study Results

  • SIFROL ® , MIRAPEX ® - Fibromyalgia
    Clinical Study Number 248.637
    Study Indication Fibromyalgia
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase II/III
    Study Title

    A randomized, double-blind, placebo-controlled, dose titration, efficacy and safety study of Pramipexole ER (0.75 mg to 4.5 mg) administered orally once daily versus placebo over a 16-week maintenance phase in patients diagnosed with fibromyalgia as assessedby the American College of Rheumatology (ACR) criteria, followed by a 24-week open-label extension phase

    Study Document
    Trial synopsis 248.637_DS_CO english