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