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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03231878

Acronym

Advance

Enrollment

105

Registered

2017-07-27

Start date

2017-12-08

Completion date

2025-03-06

Last updated

2025-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenoleukodystrophy

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 the efficacy and safety of MIN-102 treatment. Study sites will consist of specialist referral centers experienced in the management of adrenoleukodystrophy (ALD).

Interventions

DRUGMIN-102

MIN-102 treatment

DRUGPlacebos

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of MIN-102 on the progression of adrenomyeloneuropathy (AMN) in male patients as determined by a motor function test.	in 96 weeks

Secondary

Measure	Time frame
To evaluate the efficacy of MIN-102 in terms of patient reported outcomes.	in 96 weeks
SSPROM (Severity Score System for Progressive Myelopathy )	in 96 weeks
EDSS (Expanded Disability Status Scale )	in 96 weeks
Quality of life scales (Euroqol)	in 96 weeks
Incidence of cerebral inflammatory lesions	in 96 weeks

Countries

France, Germany, Hungary, Italy, Netherlands, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026