A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients.
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Adrenoleukodystrophy
In brief
This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter, two parallel-group study in male patients with the 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).
Key facts
- Study ID
- NCT03231878
- Run by
- Minoryx Therapeutics, S.L.
- People needed
- 105
- Starts
- 2017-12-08
- Expected to finish
- 2025-03-06
- Last updated by the study team
- 2025-03-18
Who can join
Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Male and between 18-65 years of age.
- Diagnosed with X-linked adrenoleukodystrophy (X-ALD) based on elevated VLCFA and genetic testing.
- Clinical evidence of spinal cord involvement.
You may not qualify if…
- Any other chronic neurological disease with signs of spastic paraplegia, such as hereditary spastic paraplegia, multiple sclerosis, etc.
- Presence of inflammatory (Gd-enhancing) MRI lesions or any abnormality other than those mentioned in the inclusion criteria.
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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