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Tests treatment safety and results for Cerebral Adrenoleukodystrophy (cALD)
Official title A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adult Male Subjects With Cerebral Adrenoleukodystrophy
ClinicalTrials.gov ID: NCT05819866
What this study is testing
What is Leriglitazone?
Leriglitazone is an investigational medicine, given as an once-daily, being studied as a potential treatment for cerebral adrenoleukodystrophy (cald).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adults Male Subjects with Cerebral Adrenoleukodystrophy.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Subject is male and aged ≥18 years.
- Subject has progressive cALD, defined as GdE+ brain lesions.
- people for whom HSCT is not recommended by the investigator or subject is not willing to undergo HSCT.
- Subject has a Loes score ≥0.5 and ≤12 at Screening.
- Subject does not have major functional disability in the Major Functional Disabilities-Neurological Function Score (MFD-NFS), except for "wheelchair...
You likely can't join if
- Subject who had previous bone marrow transplantation (HSCT) or treatment with ex-vivo gene therapy (eli-Cel).
- Subject has known type 1 or type 2 diabetes.
- Subject has known hypersensitivity or intolerance to pioglitazone or any other thiazolidinedione.
- Subject is taking or has taken honokiol, pioglitazone, or other thiazolidinediones within 3 months prior to Screening.
- Subject with current participation in another treatment clinical study or within 1 month prior to Screening.
- Subject with other medical, neuropsychiatric or social conditions that, in the opinion of the investigator, are likely to adversely affect the...
See the full eligibility criteria
- Subject is male and aged ≥18 years.
- Subject has progressive cALD, defined as GdE+ brain lesions.
- people for whom HSCT is not recommended by the investigator or subject is not willing to undergo HSCT.
- Subject has a Loes score ≥0.5 and ≤12 at Screening.
- 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...
- 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. Key
- Subject who had previous bone marrow transplantation (HSCT) or treatment with ex-vivo gene therapy (eli-Cel).
- Subject has known type 1 or type 2 diabetes.
- Subject has known hypersensitivity or intolerance to pioglitazone or any other thiazolidinedione.
- Subject is taking or has taken honokiol, pioglitazone, or other thiazolidinediones within 3 months prior to Screening.
- Subject with current participation in another treatment clinical study or within 1 month prior to Screening.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Gainesville, Florida, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Minneota, Minnesota, United States
- Salt Lake City, Utah, United States
- Buenos Aires, Argentina
- São Paulo, Brazil
- Paris, France
- Leipzig, Germany
- New Delhi, India
- Madrid, Spain
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Gainesville, Florida, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Minneota, Minnesota, United States; Salt Lake City, Utah, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.