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    The ADVANCE Clinical Study in AMN
    Home Clinical Studies ADVANCE
  • The ADVANCE Clinical Study for AMN

    The ADVANCE trial was a pivotal phase 2/3 randomized, double-blind, placebo-controlled, clinical study with an open-label extension still ongoing that was designed to assess the efficacy and safety of leriglitazone in male patients with adrenomyeloneuropathy (AMN).

    The study was divided into two parts. The first part was a two-year double blind placebo-controlled phase with a 2:1 (active:placebo) randomization, aimed to measure multiple efficacy and safety parameters. This was followed by a still active open-label extension where all patients who completed the first part are treated on active.

    The study was designed with input from both EMA and FDA, as well as EU and US clinical experts in X-ALD and patient advocacy groups.

    The ADVANCE study recruited 116 patients and results from the double-blind phase showed reduction of cerebral lesion progression and reduction of progression of myelopathy symptoms. Therefore, The marketing authorization application (MAA) for adult male X-ALD patients is under review by the EMA and hence, the launch preparations in the EU are underway. Also, discussions are currently ongoing with the FDA to define the next steps for its US approval path.

    For further information visit:
    https://clinicaltrials.gov/ct2/show/NCT03231878?term=NCT03231878&rank=1

    Hospitals involved in ADVANCE Clinical Study
    See map
    ICM, Groupe Hospitalier Pitié Salpêtrière
    Paris
    France
    Universitat Leipzig Klinik and Poliklinik für Neurologie
    Leipzig
    Germany
    Institute of Genomic Medicine and Rare Disorders
    Budapest
    Hungary
    Instituto Neurologico Carlo Besta
    Milano
    Italy
    Academish Medisch Centrum
    Amsterdam
    Netherlands
    Hospital Universitari Vall d'Hebrón
    Barcelona
    Spain
    National hospital for Neurology and Neurosurgery Charles Dent Metabolic Unit
    London
    United Kingdom
    Massachusetts General Hospital
    Boston, Massachusetts
    United States
    Kennedy Krieger Institute
    Baltimore, Maryland
    United States
    Stanford University Medical Center
    Stanford, California
    United States
    Hospitals involved in ADVANCE Clinical Study
    See list
    Map
    ICM, Groupe Hospitalier Pitié Salpêtrière
    Paris
    France
    Universitat Leipzig Klinik and Poliklinik für Neurologie
    Leipzig
    Germany
    Institute of Genomic Medicine and Rare Disorders
    Budapest
    Hungary
    Instituto Neurologico Carlo Besta
    Milano
    Italy
    Academish Medisch Centrum
    Amsterdam
    Netherlands
    Hospital Universitari Vall d'Hebrón
    Barcelona
    Spain
    National hospital for Neurology and Neurosurgery Charles Dent Metabolic Unit
    London
    United Kingdom
    Massachusetts General Hospital
    Boston, Massachusetts
    United States
    Kennedy Krieger Institute
    Baltimore, Maryland
    United States
    Stanford University Medical Center
    Stanford, California
    United States
  • Contact

    Feel free to contact us in case you are interested in any of these clinical studies

    info@minoryx.com
    +34 93 544 14 66
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