The ADVANCE Clinical Study in AMN
- 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=1Hospitals involved in ADVANCE Clinical StudySee mapICM, Groupe Hospitalier 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
ICM, Groupe Hospitalier 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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