A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients.
NCT ID: NCT03231878
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
105 participants
INTERVENTIONAL
2017-12-08
2025-03-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active
MIN-102
MIN-102 treatment
Placebo
Placebos
Placebo
Interventions
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MIN-102
MIN-102 treatment
Placebos
Placebo
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with X-linked adrenoleukodystrophy (X-ALD) based on elevated VLCFA and genetic testing.
* Clinical evidence of spinal cord involvement.
* Known type 1 or type 2 diabetes.
* Known intolerance to pioglitazone or any other thiazolidinedione.
* Taking or have taken honokiol, pioglitazone or other thiazolidinediones within the 6 months prior to screening.
* Previous bone marrow transplantation.
* Previous or current history of cancer (other than treated basal cell carcinoma).
* Previous or current history of congestive heart failure.
Exclusion Criteria
18 Years
65 Years
MALE
No
Sponsors
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Minoryx Therapeutics, S.L.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Kohler W, Engelen M, Eichler F, Lachmann R, Fatemi A, Sampson J, Salsano E, Gamez J, Molnar MJ, Pascual S, Rovira M, Vila A, Pina G, Martin-Ugarte I, Mantilla A, Pizcueta P, Rodriguez-Pascau L, Traver E, Vilalta A, Pascual M, Martinell M, Meya U, Mochel F; ADVANCE Study Group. Safety and efficacy of leriglitazone for preventing disease progression in men with adrenomyeloneuropathy (ADVANCE): a randomised, double-blind, multi-centre, placebo-controlled phase 2-3 trial. Lancet Neurol. 2023 Feb;22(2):127-136. doi: 10.1016/S1474-4422(22)00495-1.
Other Identifiers
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MT-2-01
Identifier Type: -
Identifier Source: org_study_id
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