Value through Innovation27 July 2016

Clinical Study Results

  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.653
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    A regulatory requirement post-marketing surveillance study to monitor safety   and effectiveness of Mirapex (Pramipexole, 0.125mg, 0.25mg, 0.5mg, 1mg, q.d)  in Korean patients with primary Restless Leg Syndrome (RLS)

    Study Document Trial synopsis 248.653_DR english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.543
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    A randomized, double-blind, placebo-controlled, parallel group clinical trial comparing fixed doses of 0.25 mg, 0.50 mg and 0.75 mg pramipexole (Mirapex®) administered orally to investigate the safety and efficacy in patients with idiopathic restless legs syndrome for 12 weeks

    Study Document Trial synopsis 248.543_CO english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.546
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    A double-blind, placebo-controlled, randomised withdrawal study of 3 month duration in patients suffering from idiopathic Restless Legs Syndrome who responded to a preceding, 6-month treatment with open-label pramipexole including titration (0.125, 0.25, 0.5, 0.75 mg orally q.n.)

    Study Document Trial synopsis 248.546_CO english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.557
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomized, double-blind, placebo-controlled trial with 0.75mg pramipexole (BIoSifrol®) orally once daily to investigate the efficacy and safety for 6 weeks in patients with primary Restless Legs Syndrome.

    Study Document Trial synopsis 248.557_CO english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.600
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IIa
    Study Title

    An open-label clinical study to investigate pharmacokinetics (PK) of different doses (0.125 mg, 0.25 mg, 0.5 mg) of pramipexole administered once daily orally in pediatric patients who are individually optimized to stable pramipexole doses for the treatment of idiopathic Restless Legs Syndrome (RLS)

    Study Document Trial synopsis 248.600_CO english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.604
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    A phase IV randomised, double-blind, placebo-controlled, dose titration trial with 0.125-0.75 mg/day pramipexole (Sifrol®, Mirapexin®) orally for 12 weeks to investigate the safety and efficacy in out-patients with idiopathic Restless Legs Syndrome associated with mood disturbances

    Study Document Trial synopsis 248.604_DR english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.615
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    A phase IV randomised, double-blind, placebo-controlled, dose titration trial with pramipexole (Sifrol®, Mirapexin®) 0.125-0.75 mg/day per os for 12 weeks to investigate the effects on RLS symptoms (IRLS) and sleep disturbance (MOS sleep scale) in out-patients with idiopathic Restless Legs Syndrome

    Study Document Trial synopsis 248.615_DR english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.616
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    A Phase IV randomised, double-blind, active and placebo-controlled, 6-week trial to investigate the efficacy and safety of a starting (and fixed) dose 0.25 mg pramipexole (Mirapex®) in patients with idiopathic Restless Legs Syndrome

    Study Document Trial synopsis 248.616_CO english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.618
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Sifrol - Onset of action and impact on RLS: A 12-week observational study in patients with primary RLS

    Study Document Trial synopsis 248.618_CO english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.623
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Sifrol (Pramipexole) impact on RLS: A 12-weeks observational study in patients with primary RLS

    Study Document Trial synopsis 248.623_CO english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.627
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind study to evaluate the efficacy and safety of pramipexole at fixed doses of 0.25 mg, 0.5 mg, and 0.75 mg in patients with idiopathic restless legs syndrome for 6 weeks, followed by a 46-week open-label long-term study to evaluate the safety and efficacy of pramipexole

    Study Document Trial synopsis 248.627_DS_CO english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.629
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    A phase IV randomised, double-blind, placebo-controlled, dose titration trial with pramipexole (Sifrol®, Mirapexin®) 0.125-0.75 mg/day per os to investigate the long-term efficacy, safety and tolerability in patients with idiopathic moderate to severe Restless Legs Syndrome for 26 weeks

    Study Document Trial synopsis 248.629_DR english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.630
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    A randomized, double-blind, placebo controlled dose titration trial with 0.125-0.75mg Pramipexole (Sifrol®) orally q.n. to investigate the safety and efficacy in out-patients with idiopathic Restless Legs Syndrome for 6 weeks

    Study Document Trial synopsis 248.630_DS_CO english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.632
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Epidemiological study on the frequency of the RLS in patients with chronic insomnia in the general practice medicine setting

    Study Document Trial synopsis 248.632_CO english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.515
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IIb
    Study Title

    A double-blind, placebo-controlled dose-finding study to investigate efficacy and safety of different doses (0.125, 0.25, 0.5, 0.75 mg) of pramipexole administered once daily orally over three weeks in patients with idiopathic restless legs syndrome (RLS), followed by a 26-week open-label dose-finding study (0.125 mg – 0.75 mg) to investigate long-term efficacy of pramipexole in patients with RLS.

    Study Document Trial synopsis 248.515_CO english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.518
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    Swiss Restless Legs Syndrome Trial (SRLS). A double-blind, randomised, crossover trial investigating the efficacy and safety of the dopamine agonist pramipexole (Sifrol®, 0.25-0.75 mg per day) versus levodopa / benserazide (Madopar® DR, 125-375 mg per day) in patients with restless legs syndrome

    Study Document Trial synopsis 248.518_CO english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.520
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled dose titration trial with 0.125-0.75 mg pramipexole (Sifrol®) orally to investigate the safety and efficacy in out-patients with idiopathic Restless Legs Syndrome for 6 weeks followed by 46 weeks open-label or double-blind treatment period

    Study Document Trial synopsis 248.520_CO english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.638
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Sifrol (Pramipexole) impact on RLS related Quality of Life: A 12-weeks observational non-interventional Study in patients with primary RLS

    Study Document Trial synopsis 248.638_CO english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.659
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Influence of Pramipexole (PPX) on sensory symptoms in patients with Restless Legs Syndrome (RLS)

    Study Document Trial synopsis 248.659_DS_CO english
  • SIFROL ® , MIRAPEX ® - Restless Legs Syndrome
    Clinical Study Number 248.678
    Study Indication Restless Legs Syndrome
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Special Survey on Long-Term Drug Use of BI-Sifrol® Tablets in Patients with Restless Legs Syndrome

    Study Document Trial synopsis 248.678_CO english

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