RECRUITING

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

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Conditions

Cerebral Adrenoleukodystrophy (cALD)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-07-12
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05819866

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is male and aged ≥18 years.
  2. * Subject has progressive cALD, defined as GdE+ brain lesions.
  3. * Subjects for whom HSCT is not recommended by the investigator or subject is not willing to undergo HSCT.
  4. * Subject has a Loes score ≥0.5 and ≤12 at Screening.
  5. * Subject does not have major functional disability in the Major Functional Disabilities-Neurological Function Score (MFD-NFS), except for "wheelchair bound" or "total incontinence", which will be allowed as these are considered expected symptoms of AMN in the time course of the disease
  6. * Subject does not have major cognitive impairment which would impair his ability to take part in the study as determined by the investigator at screening.
  1. * Subject who had previous bone marrow transplantation (HSCT) or treatment with ex-vivo gene therapy (eli-Cel).
  2. * Subject has known type 1 or type 2 diabetes.
  3. * Subject has known hypersensitivity or intolerance to pioglitazone or any other thiazolidinedione.
  4. * Subject is taking or has taken honokiol, pioglitazone, or other thiazolidinediones within 3 months prior to Screening.
  5. * Subject with current participation in another interventional clinical study or within 1 month prior to Screening.
  6. * Subject with other medical, neuropsychiatric or social conditions that, in the opinion of the investigator, are likely to adversely affect the risk-benefit of study participation, interfere with study compliance, or confound the study results.

Contacts and Locations

Study Locations (Sites)

Stanford University Medical Center
Palo Alto, California, 94304-5978
United States
Neuro Medicine Hospital / UF Health
Gainesville, Florida, 32608
United States
Kennedy Krieger Institute
Baltimore, Maryland, 21205
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Minnesota
Minnesota, Minnesota, 55455
United States
Health University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Minoryx Therapeutics, S.L.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-12
Study Completion Date2027-05

Study Record Updates

Study Start Date2023-07-12
Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

  • Cerebral Adrenoleukodystrophy (cALD)