A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients. (Advance)
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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).
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
Actual Study Start Date :
December 8, 2017
Estimated Primary Completion Date :
Estimated Study Completion Date :
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Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.