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Completed NCT03231878

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

Conditions: Adrenoleukodystrophy

Sex: Male
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 116
Sponsor: Minoryx Therapeutics, S.L.

Location: Stanford University Medical Center Stanford California

Summary

This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter, two parallel-group study in male patients with the adrenomyeloneuropathy (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).

Eligibility Criteria

Inclusion Criteria for Part 1 of the study: * Male and between 18-65 years of age. * Diagnosed with X-ALD based on genetic testing. * Clinical evidence of spinal cord involvement. Additional Inclusion Criteria for Part 2 of the study: \- Completion of the entire 96-week double-blind period of the study (Part 1). Exclusion Criteria for both parts of the study: * 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03231878). StuddyBuddy aggregates publicly available trial information.