- The NEXUS Clinical Study in cALD
The NEXUS trial is a phase 2/3, open-label clinical study that has been designed to assess the efficacy and safety of leriglitazone in pediatric patients with early stage cerebral adrenoleukodystrophy (cALD). This study is part of the Pediatric Investigational Plan (PIP) approved by EMA for leriglitazone in X-ALD.
The NEXUS study has recruited 23 cALD patients with first evidence of cerebral MRI lesions. All patients will be receiving leriglitazone and they will be carefully monitored for safety, changes in clinical symptoms and in cerebral MRI lesions. The study has been designed with input from both EMA and FDA, and EU and US clinical experts in X-ALD and patient advocacy groups. The study design does not interfere with the current Standard of Care and does not delay haematopoietic stem cell transplantation if it becomes indicated.
For further information visit:
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-000654-59Hospitals involved in NEXUS Clinical StudySee mapICM, Groupe Hospitalier Pitié SalpêtrièreParisFranceUniversity Medical Center Hamburg-EppendorfHamburgGermanyKlinik für Kinder- und JugendmedizinGöttingenGermanyHospital Sant Joan de DéuBarcelonaSpainHospitals involved in NEXUS Clinical StudySee listICM, Groupe Hospitalier Pitié SalpêtrièreParisFranceUniversity Medical Center Hamburg-EppendorfHamburgGermanyKlinik für Kinder- und JugendmedizinGöttingenGermanyHospital Sant Joan de DéuBarcelonaSpain