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A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients
Sponsor: Minoryx Therapeutics, S.L.
Summary
This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter, two parallel-group study in male patients with the adrenomyeloneuropathy (AMN) phenotype of X-linked adrenoleukodystrophy (X-ALD) to assess the efficacy and safety of MIN-102 treatment. Study sites will consist of specialist referral centers experienced in the management of adrenoleukodystrophy (ALD).
Official title: A Randomized, Double-blind, Placebo-controlled, Multinational, Multicenter Study With Open-label Treatment Extension to Assess the Effect of MIN-102 on the Progression of Adrenomyeloneuropathy in Male Patients With X-linked Adrenoleukodystrophy
Key Details
Gender
MALE
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2017-12-08
Completion Date
2025-03-06
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
Leriglitazone
Administered once daily in the morning. Dosing was adjusted on an individual-patient basis to achieve target plasma leriglitazone exposure, with a maximum allowed range of ±20%.
Placebo
Administered once daily in the morning. Patients randomized to placebo received the same amount of a matched placebo suspension.
Locations (10)
Stanford University Medical Center
Stanford, California, United States
Kennedy Krieger Institute
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Hospital de la 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
Milan, 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