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

A Randomized, Double-blind, Placebo-controlled, Multinational, Multicenter Study With Open-label Treatment Extension to Assess the Effect of MIN-102 (IMP) on the Progression of Adrenomyeloneuropathy in Male Patients With X-linked Adrenoleukodystrophy

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).

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.