NCT03231878

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
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Minoryx Therapeutics, S.L. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Adrenoleukodystrophy

Interventions

Type	Name	Description
DRUG	MIN-102	MIN-102 treatment
DRUG	Placebos	Placebo

Timeline

• Start date: 2017-12-08
• Primary completion: 2021-06-25
• Completion: 2025-03-06
• First posted: 2017-07-27
• Last updated: 2025-03-18

Locations

10 sites across 8 countries: United States, France, Germany, Hungary, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study