Trial | NCT03231878  Report issue

Title

A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients.
A Randomized, Double-blind, Placebo-controlled, Multinational, Multicenter Study With Open-label Treatment Extension to Assess the Effect of MIN-102 (IMP) on the Progression of Adrenomyeloneuropathy in Male Patients With X-linked Adrenoleukodystrophy

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Intervention/Treatment

    MIN-102 ...

  • Study Participants

    105
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).
Study Started
Dec 08
2017
Primary Completion
Jun 25
2021
Study Completion
Jun 30
2025
Anticipated
Last Update
Nov 29
2023

Drug MIN-102

MIN-102 treatment

Drug Placebos

Placebo

Active Active Comparator

Placebo Placebo Comparator

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.
No Results Posted