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

Minoryx

Status and phase

Completed

Phase 3

Phase 2

Conditions

Adrenoleukodystrophy

Treatments

Drug: MIN-102

Drug: Placebos

Study type

Interventional

Funder types

Industry

Identifiers

NCT03231878

MT-2-01

Details and patient eligibility

About

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).

Enrollment

105 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.