LEDIANT REGISTRY
As a condition of the marketing authorization under exceptional circumstances by the European Medicines Agency, the marketing authorization holder must maintain a patient registry for individuals with Cerebrotendinous xanthomatosis treated with chenodeoxycholic acid. The registry collects long-term real-world data on safety and effectiveness, including adverse events, liver function, and disease progression, to support ongoing evaluation of the medicine’s benefit–risk balance.
https://www.ema.europa.eu/en/medicines/human/EPAR/chenodeoxycholic-acid-leadiant
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CALYX : A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adults Male Subjects with Cerebral Adrenoleukodystrophy.
Clinical Trial ID: NCT05819866
This ongoing phase 3 randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of leriglitazone in adult males with cerebral adrenoleukodystrophy who are not candidates for hematopoietic stem cell transplantation. Participants are assigned to receive either leriglitazone or placebo and are followed over 3 years. The primary endpoint is the time to major disease progression, defined as death or severe disability requiring permanent ventilatory support. Secondary outcomes include changes in MRI severity (Loes score).
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ADVANCE: A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients
ClinicalTrials.gov ID NCT03231878
This international multicenter therapeutic trial is testing the efficacy and safety of leriglitazone in men with adrenomyeloneuropathy. The study is now completed.
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IGNITE: A Study of VGL101 in Patients With Adult-Onset Leukoencephalopathy With Axonal Spheroids and Pigmented Glia
ClinicalTrials.gov ID NCT05677659
This international multicenter therapeutic trial, conducted by VIGIL, aims to evaluate the therapeutic benefit of a monoclonal antibody targeting the TREM2 protein in CSF1R-related leukodystrophy.
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