Actively Recruiting

Phase 3
Age: 18Years +
MALE
NCT05819866

A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adult Male Subjects With Cerebral Adrenoleukodystrophy

Led by Minoryx Therapeutics, S.L. · Updated on 2025-11-17

40

Participants Needed

13

Research Sites

198 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adults Male Subjects with Cerebral Adrenoleukodystrophy.

CONDITIONS

Official Title

A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adult Male Subjects With Cerebral Adrenoleukodystrophy

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male aged 18 years or older
  • Diagnosed with progressive cerebral adrenoleukodystrophy (cALD) shown by gadolinium-enhancing brain lesions
  • Not recommended for or unwilling to undergo hematopoietic stem cell transplantation (HSCT)
  • Loes score between 0.5 and 12 at screening
  • No major functional disability except wheelchair use or total incontinence allowed
  • No major cognitive impairment that would prevent participation as assessed by investigator
Not Eligible

You will not qualify if you...

  • Previous bone marrow transplantation (HSCT) or ex-vivo gene therapy (eli-Cel)
  • Known type 1 or type 2 diabetes
  • Known allergy or intolerance to pioglitazone or other thiazolidinediones
  • Use of honokiol, pioglitazone, or other thiazolidinediones within 3 months before screening
  • Current participation in another interventional clinical study or within 1 month prior to screening
  • Other medical, neuropsychiatric, or social conditions likely to affect study safety, compliance, or results as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

Stanford University Medical Center

Palo Alto, California, United States, 94304-5978

Actively Recruiting

2

Neuro Medicine Hospital / UF Health

Gainesville, Florida, United States, 32608

Withdrawn

3

Kennedy Krieger Institute

Baltimore, Maryland, United States, 21205

Actively Recruiting

4

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

5

University of Minnesota

Minneota, Minnesota, United States, 55455

Actively Recruiting

6

Health University of Utah

Salt Lake City, Utah, United States, 84112

Withdrawn

7

Hospital Austral

Buenos Aires, Argentina

Actively Recruiting

8

Federal University of Sao Paulo

São Paulo, Brazil

Actively Recruiting

9

ICM La Pitie Salpetriere

Paris, France, 75013

Actively Recruiting

10

Klinik und Poliklinik für Neurologie-Leipzig

Leipzig, Germany, 04103

Actively Recruiting

11

Sir Ganga Ram Hospital

New Delhi, India, 110060

Actively Recruiting

12

Hospital 12 de Octubre

Madrid, Spain, 28041

Actively Recruiting

13

National Hospital for Neurology and Neurosurgery

London, United Kingdom, WC1N 3AX

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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