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COMPLETED
NCT03231878
PHASE2/PHASE3

A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients

Sponsor: Minoryx Therapeutics, S.L.

View on ClinicalTrials.gov

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

Interventions

DRUG

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%.

DRUG

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