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