Overview
A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients.
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2023-06-01
2023-06-01
Target enrollment:
0
0
Participant gender:
Male
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 3Accepts Healthy Volunteers?
NoDetails
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.