Status:

UNKNOWN

A Clinical Study in Male Pediatric Patients With Cerebral X-linked Adrenoleukodystrophy (Cald) to Assess the Effects of MIN-102 Treatment on Disease Progression Prior to Human Stem Cell Transplant (HSCT)

Lead Sponsor:

Minoryx Therapeutics, S.L.

Conditions:

Cerebral Adrenoleukodystrophy

Eligibility:

MALE

2-12 years

Phase:

PHASE2

Brief Summary

An Open-Label, multicenter study in male pediatric patients with cerebral x-linked adrenoleukodystrophy (cald) to assess the effects of MIN-102 treatment on disease progression prior to human stem cel...

Eligibility Criteria

Inclusion

  • Males aged ≥2 and ≤12 years with a diagnosis of X-linked ALD
  • White matter involvement as determined by cerebral MRI lesions without Gd enhancement at baseline (Population 1), or with Gd enhancement at baseline (Population 2).
  • Major Functional Disabilities (MFD) score of 0.
  • Baseline Loes score \>0 and ≤10
  • Gadolinium Intensity Score \>2

Exclusion

  • Previous HSCT
  • Too far progressed inflammatory brain lesions

Key Trial Info

Start Date :

September 13 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2023

Estimated Enrollment :

13 Patients enrolled

Trial Details

Trial ID

NCT04528706

Start Date

September 13 2019

End Date

December 31 2023

Last Update

July 18 2023

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Hernan Amartino

Bueno Aires, Buenos Aires, Argentina, B16641NZ

2

CHU Kremlin Bicêtre

Paris, France

3

Universitätsmedizin Göttingen Georg-August-Universität

Göttingen, Germany

4

Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik für Kinder- und Jugendmedizin

Hamburg, Germany