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

• Status: Active, not recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Minoryx Therapeutics, S.L.

Criteria

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.