Status:
COMPLETED
A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients.
Lead Sponsor:
Minoryx Therapeutics, S.L.
Conditions:
Adrenoleukodystrophy
Eligibility:
MALE
18-65 years
Phase:
PHASE2
PHASE3
Brief 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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2025
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT03231878
Start Date
December 8 2017
End Date
March 6 2025
Last Update
March 18 2025
Active Locations (10)
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1
Stanford University Medical Center
Stanford, California, United States, 94304
2
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Hospital de la Pitié-Salpêtrière
Paris, France