Value through Innovation27 July 2016

Clinical Study Results

  • 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
  • MIRAPEX ® - Healthy
    Clinical Study Number 248.665
    Study Indication Healthy
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase I
    Study Title

    A multiple dose bioequivalence study of pramipexole with increasing doses (0.375 mg to 1.5 mg q.d.) of oral extended release (ER) tablet in two-way cross-over comparison of 0.375 mg extended release tablet q.d. versus 0.125 mg immediate release (IR) tablet t.i.d and 1.5 mg extended release tablet q.d. versus 0.5 mg immediate release tablet t.i.d. in Chinese healthy male volunteers

    Study Document Trial synopsis 248.665_DS_CO english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.524
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson’s disease (PD)

    Study Document Trial synopsis 248.524_DR english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.525
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IIIa
    Study Title

    A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD)

    Study Document Trial synopsis 248.525_DR english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.538
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    A two year open label, randomized, parallel group, blinded assessment ophthalmologic safety study of pramipexole IR versus ropinirole in early Parkinson’s Disease patients

    Study Document Trial synopsis 248.538_DS_CO english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.633
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    Long-term safety study of open-label pramipexole extended release (ER) in patients with early Parkinson’s disease (PD)

    Study Document Trial synopsis 248.633_DR english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.634
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    Long-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson

    Study Document Trial synopsis 248.634_DR english
  • 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
  • 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
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.544
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Open label, exploratory clinical trial to assess the safety, tolerability and effectiveness of a switching from talipexole to pramipexole

    Study Document Trial synopsis 248.544_CO english
  • 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
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.547
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance of BI-Sifrol® (Pramipexole). Special survey on patients with Parkinson's disease on long-term treatment

    Study Document Trial synopsis 248.547_DR english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.549
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance of BI-Sifrol® (Pramipexole). Special drug use result survey in 3 years treatment in patients with Parkinson

    Study Document Trial synopsis 248.549_DR english
  • 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
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.559
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Clinical Study On Pramipexole’s Efficacy and Safety in Patients with Parkinson’s Disease (COPE w/ PD)

    Study Document Trial synopsis 248.559_CO english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.595
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease

    Study Document Trial synopsis 248.595_DR english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.596
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo, administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms

    Study Document Trial synopsis 248.596 english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.598
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Observational Study Concerning the Titration Schedule of SIFROL ® (Pramipexole).

    Study Document Trial synopsis 248.598_CO english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.599
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Mirapex PMS study final report

    Study Document Trial synopsis 248.599_CO english
  • 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
  • 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
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.610
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IIb/III
    Study Title

    A double-blind, double-dummy, randomised, parallel-group study to investigate the safety, tolerability, trough plasma concentration, and efficacy of pramipexole ER versus pramipexole IR administered orally for 12 weeks in patients with Parkinson’s disease (PD) on L-dopa therapy, followed by a 52-week open-label long-term treatment period to evaluate the long-term safety and efficacy of pramipexole ER

    Study Document Trial synopsis 248.610_DS_CO english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.613
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    CEE PMSS (Central Eastern European Post-Marketing Surveillance Study) "First Presentation"of MIRAPEXIN in Parkinson Patients

    Study Document Trial synopsis 248.613_DR english
  • 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
  • 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
  • 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
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.619
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    A cross-sectional, retrospective screening and case-control study examining the frequency of, and risk factors associated with, impulse control disorders in Parkinson’s disease patients treated with MIRAPEX® (pramipexole) and other anti-parkinson agents (DOMINION Study)

    Study Document Trial synopsis 248.619_CO english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.622
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    A randomized, double-blind, active (pramipexole 0.5 mg tid) and placebo controlled, efficacy study of pramipexole given 0.5 mg and 0.75 mg bid over a 12-week treatment phase in early Parkinson’s disease patients (PramiBID)

    Study Document Trial synopsis 248.622_DS_CO english
  • 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
  • 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
  • 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
  • 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
  • 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
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.337
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase II
    Study Title

    Early Phase II study of SND 919 tablets in Parkinson’s disease

    Study Document Trial synopsis 248.337_CO english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.360
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Observation of the efficacy and tolerability of Sifrol® in patients with advanced idiopathic Parkinson’s disease

    Study Document Trial synopsis 248.360_CO english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.505
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    A double-blind, placebo-controlled, randomized, multicenter trial to compare the safety and efficacy of oral administration or pramipexole up to 4.5 mg and bromocriptine up to 22.5 mg combined with L-dopa in advanced Parkinson’s disease

    Study Document Trial synopsis 248.505_CO english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.506
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    Long-term administration study of SND 919 tablets in Parkinson

    Study Document Trial synopsis 248.506_CO english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.511
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    The effect of Sifrol® on tremor and depression in patients with idiopathic Parkinson’s disease patients. Observational study

    Study Document Trial synopsis 248.511_CO english
  • 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
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.516
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomized single-blind placebo controlled comparative trial of Pramipexole tablets and Bromocriptine tablets in patients with Parkinson’s disease.

    Study Document Trial synopsis 248.516_CO english
  • 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
  • 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
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.527
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Management of Parkinson´s Disease patients at their first visits in a neurological practice

    Study Document Trial synopsis 248.527_CO english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.539
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Post marketing surveillance study of Sifrol - Monotherapy in patients with idiopathic Parkinson

    Study Document Trial synopsis 248.539_CO english
  • 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
  • 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 ® - Parkinson Disease
    Clinical Study Number 248.649
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Non-motor symptoms (depressive symptoms) of Parkinson’s disease and their course under pramipexole treatment

    Study Document Trial synopsis 248.649_DR english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.655
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Sifrol onset of action and impact on RLS: a 12-weeks observational study in patients with primary RLS

    Study Document Trial synopsis 248.655_DR english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.657
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Kinetic tremor in Parkinsons disease: its course under Mirapexin® treatment and impact on Quality of Life

    Study Document Trial synopsis 248.657_DR english
  • 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
  • MIRAPEX ® - Healthy
    Clinical Study Number 248.677
    Study Indication Healthy
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase I
    Study Title

    A multiple dose study with increasing dose for pramipexole extended release (ER) tablet (0.375 mg q.d. to 1.5 mg q.d.) in two-way cross-over comparison to investigate the bioequivalence of 1.5 mg ER x 1 tablet q.d. versus 0.375 mg ER x 4 tablets q.d. under fasted and fed conditions in Japanese healthy male volunteers

    Study Document Trial synopsis 248.677_DS_CO english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.636
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    A double-blind, double-dummy, randomized, parallel groups study to assess the Efficacy, Safety and Tolerability of switching patients with early Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ER or Pramipexole IR.

    Study Document Trial synopsis 248.636_DR english
  • 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
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.635
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Post marketing surveillance of BI-Sifrol® (Pramipexole). Special drug use result survey in Parkinson’s disease patients with depressive symptoms

    Study Document Trial synopsis 248.635_DR english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.674
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Influence of Pramipexole extended release on medication adherence in real life care of Parkinson’s disease

    Study Document Trial synopsis 248.674_DR english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.671
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    A double-blind, double-dummy, randomised, parallel-group study comparing the efficacy, safety, and tolerability of pramipexole ER versus pramipexole IR administered orally for 18 weeks in Chinese Parkinson's disease (PD) patients who can be concomitantly treated with L-dopa

    Study Document Trial synopsis 248.671_DS_CO english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.682
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Safety of Pramipexole monotherapy or combination therapy in Chinese patients   with Parkinson’s disease: a 12-week post-marketing surveillance

    Study Document Trial synopsis 248.682_CO english
  • 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
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.342
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase I
    Study Title

    Matched pair, assessor blinded, open label clinical trial to assess the ophthalmologic safety of ongoing long term oral treatment with pramipexole compared to bromocriptine or other dopamine agonists in patients with Parkinson's disease.

    Study Document Trial synopsis 248.342_CO english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.648
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Observational study in Parkinson's disease of the primary carepopulation of patients treated with pramipexole by neurologists in France (ETAP)

    Study Document Trial synopsis 248.648 english
  • MIRAPEX ® - Healthy
    Clinical Study Number 248.607
    Study Indication Healthy
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase I
    Study Title

    A multiple dose study of pramipexole with increasing doses (0.375 mg to 1.5 mg q.d.) of oral extended release (ER) tablet in two-way cross-over comparison of 0.375 mg ER tablet q.d. versus 0.125 mg immediate release (IR) tablet t.i.d. and 1.5 mg ER tablet q.d. versus 0.5 mg IR tablet t.i.d. in Japanese healthy male volunteers

    Study Document Trial synopsis 248.607_CO english
  • MIRAPEX ® - Healthy
    Clinical Study Number 248.560
    Study Indication Healthy
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase I
    Study Title

    A single dose five-way cross-over study to establish an in vitro/in vivo correlation (IVIVC) for oral slow release (SR) tablets with 0.375 mg pramipexole in healthy male volunteers

    Study Document Trial synopsis 248.560 english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.548
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance of BI-Sifrol (R) (Pramipexole) Special survey on patients with Parkinson’s disease and renal dysfunction

    Study Document Trial synopsis 248.548 english
  • MIRAPEX ® - Healthy
    Clinical Study Number 248.545
    Study Indication Healthy
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, randomised, placebo-controlled study with two sequential two-way cross-over parts to demonstrate that the influence of pramipexole up to 4.5 mg daily on the QT interval of the ECG in healthy male and female volunteers is comparable with placebo, with a positive control (two-way cross-over moxifloxacin versus placebo) 

    Study Document Trial synopsis 248.545_CO english
  • MIRAPEX ® - Healthy
    Clinical Study Number 248.530
    Study Indication Healthy
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase I
    Study Title

    A multiple dose study with increasing pramipexole doses (0.375 mg to 4.5 mg q.d.) of oral sustained release (SR) tablets with a three-way cross comparison of 4.5 mg pramipexole SR q.d. fasted versus 4.5 mg pramipexole SR q.d. fed versus 1.5 mg pramipexole immediate release tablets t.i.d. fasted in healthy male volunteers 

    Study Document Trial synopsis 248.530_CO english
  • MIRAPEX ® - Healthy
    Clinical Study Number 248.529
    Study Indication Healthy
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase I
    Study Title

    A multiple dose seven-way cross-over formulation-finding study comparing the oral bioavailability of seven prototype slow-release formulations with 0.75 mg pramipexole (four days each) to immediate-release tablets at steady state in healthy male volunteers

    Study Document Trial synopsis 248.529_CO english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.517
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    SIFROL - Switch Post Marketing Surveillance Study in Patients with idiopathic Parkinson's disease

    Study Document Trial synopsis 248.517 english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.680
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Special Survey on Long-term Drug Use of Mirapex®-LA Tablets (Pramipexole extended-release) in Patients with Parkinson’s Disease

    Study Document Trial synopsis 248.680_DR english
  • MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.675
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Assessment of the safety and efficacy of pramipexole extended release in patients with Parkinson’s Disease in routine clinical practice

    Study Document Trial synopsis 248.675_DR english
  • MIRAPEX ® - 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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