A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients. (NCT03231878) | Clinical Trial Compass
CompletedPhase 2/3
A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients.
United States, France, Germany105 participantsStarted 2017-12-08
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexMALE
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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.
What they're measuring
1
To evaluate the efficacy of MIN-102 on the progression of adrenomyeloneuropathy (AMN) in male patients as determined by a motor function test.