The ADVANCE Clinical Study in AMN
- The ADVANCE Clinical Study for AMN
The ADVANCE trial is a pivotal phase 2/3 randomized, double-blind, placebo-controlled, clinical study with an open-label extension that has been designed to assess the efficacy and safety of leriglitazone in male patients with adrenomyeloneuropathy (AMN).
The study is divided into two parts. The first part is a two-year blinded placebo-controlled study with a 2:1 (active:placebo) randomization ratio to measure multiple efficacy and safety parameters. This first part is followed-up by an open-label extension study in which all patients who completed part 1 will be eligible to receive leriglitazone.
The study has been designed with input from both EMA and FDA, as well as EU and US clinical experts in X-ALD and patient advocacy groups.
Recruitment of over 100 patients in the ADVANCE study has been completed and results are expected by the end of 2020.
For further information visit:
https://clinicaltrials.gov/ct2/show/NCT03231878?term=NCT03231878&rank=1Hospitals involved in ADVANCE Clinical StudySee mapHospital de la Pitié-SalpêtrièreParisFranceUniversitat Leipzig Klinik and Poliklinik für NeurologieLeipzigGermanyInstitute of Genomic Medicine and Rare DisordersBudapestHungaryInstituto Neurologico Carlo BestaMilanoItalyAcademish Medisch CentrumAmsterdamNetherlandsHospital Universitari Vall d'HebrónBarcelonaSpainNational hospital for Neurology and Neurosurgery Charles Dent Metabolic UnitLondonUnited KingdomMassachusetts General HospitalBoston, MassachusettsUnited StatesKennedy Krieger InstituteBaltimore, MarylandUnited StatesStanford University Medical CenterStanford, CaliforniaUnited StatesHospitals involved in ADVANCE Clinical StudySee list
Hospital de la Pitié-SalpêtrièreParisFranceUniversitat Leipzig Klinik and Poliklinik für NeurologieLeipzigGermanyInstitute of Genomic Medicine and Rare DisordersBudapestHungaryInstituto Neurologico Carlo BestaMilanoItalyAcademish Medisch CentrumAmsterdamNetherlandsHospital Universitari Vall d'HebrónBarcelonaSpainNational hospital for Neurology and Neurosurgery Charles Dent Metabolic UnitLondonUnited KingdomMassachusetts General HospitalBoston, MassachusettsUnited StatesKennedy Krieger InstituteBaltimore, MarylandUnited StatesStanford University Medical CenterStanford, CaliforniaUnited States
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