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Status unknownNCT04528706NEXUSUpdated Jul 18, 2023

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)

A Phase 2 interventional study of MIN-102 in Cerebral Adrenoleukodystrophy, sponsored by Minoryx Therapeutics, S.L.. Status unknown at 5 sites in 4 countries. Open to male participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-07-18.

Sponsored by Minoryx Therapeutics, S.L. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
2 Years to 12 Years
Sex
Male
01

Study 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 cell transplant (HSCT)

02

Conditions studied

  • Cerebral Adrenoleukodystrophy
03

Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • Previous HSCT
  • Too far progressed inflammatory brain lesions
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (estimated)

Study arms

  • Experimental
    MIN-102

    Drug: MIN-102

Interventions

  • DrugMIN-102

    Once-daily dosing with a volume specified by the pharmacokineteic specialist to achive the desired plasma exposure. Min-102 Oral suspension, strength 15mg/ml.

05

What researchers measure

Primary outcomes

  1. evaluate whether MIN-102 can halt disease progression of cALD if administered prior to hematopoietic stem-cell transplantation (HSCT), as determined by serial clinical and MRI investigations in pediatric subjects.

    Time frame: 6 months- 2 years

  2. "arrested disease" will be assessed at 24 weeks and at 96 weeks

    arrested disease is defined using: Cahnge in NFS from Baseline, Free of MFD and lack of lesion progression on MRI

    Time frame: at 24 weeks and 96 weeks

06

Study locations

5 sites
  • Hernan Amartino
    Bueno Aires, Buenos Aires B16641NZ, Argentina
  • CHU Kremlin Bicêtre
    Paris, France
  • Universitätsmedizin Göttingen Georg-August-Universität
    Göttingen, Germany
  • Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik für Kinder- und Jugendmedizin
    Hamburg, Germany
  • Hospital Sant Joan de Déu
    Barcelona, Spain
07

Registry details

Key details

Study ID
NCT04528706
Lead sponsor
Minoryx Therapeutics, S.L.
Responsible party
Sponsor
First posted
Aug 27, 2020
Start date
Sep 13, 2019
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Jul 18, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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