Value through Innovation27 July 2016

Clinical Study Results

  • SIFROL ® , MIRAPEX ® - Tourette Syndrome
    Clinical Study Number 248.644
    Study Indication Tourette Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase II
    Study Title

    A randomized, double-blind, placebo-controlled, flexible dose study to evaluate efficacy and safety of pramipexole IR (0.0625-0.5 mg/day) versus placebo for 6 weeks in children and adolescents (age 6-17 inclusive) diagnosed with Tourette’s Disorder according to DSM-IV criteria

    Study Document Trial synopsis 248.644_DS_CO english
  • SIFROL ® , MIRAPEX ® - Tourette Syndrome
    Clinical Study Number 248.642
    Study Indication Tourette Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    An open-label, flexible dose, follow-up study to evaluate safety and efficacy of oral pramipexole (0.0625 – 0.5 mg/day) for 24 weeks in children and adolescents (age 6-17 years) diagnosed with Tourette Syndrome according to DSM-IV criteria and who have completed the double-blind phase of either 248.641 or 248.644

    Study Document Trial statement 248.642_CO english Trial synopsis 248.642_DS_CO english
  • MIRAPEX ® , SIFROL ® - Tourette Syndrome
    Clinical Study Number 248.641
    Study Indication Tourette Syndrome
    Product MIRAPEX ® ; SIFROL ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III double-blind, double-dummy, placebo-controlled, 8 week fixed dose trial with pramipexole IR (Mirapex®, Mirapexin®, Pexola®, Sifrol®) 0.125 and 0.5 mg/day administered orally to investigate the efficacy and safety in patients 6-17 years of age diagnosed with Tourette Syndrome according to DSM-IV criteria

    Study Document Trial statement 248.641 english

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