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Thiazolidinedione
Leriglitazone for Adrenoleukodystrophy (CALYX Trial)
Phase 3
Recruiting
Research Sponsored by Minoryx Therapeutics, S.L.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has progressive cALD, defined as GdE+ brain lesions.
Subjects for whom HSCT is not recommended by the investigator or subject is not willing to undergo HSCT.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up interim analysis 1 (at 18 months of treatment)
Awards & highlights
CALYX Trial Summary
This trial studies the effects of a drug on adults with a rare neurological disorder called Cerebral Adrenoleukodystrophy.
Who is the study for?
This trial is for adult males with cerebral adrenoleukodystrophy (cALD) who can't or choose not to undergo a bone marrow transplant. Participants should have progressing cALD, a specific brain lesion score, and no major functional disabilities except those common in AMN progression. They must not have diabetes, previous treatments like HSCT or certain drugs within 3 months, and shouldn't be part of another study.Check my eligibility
What is being tested?
The trial is testing Leriglitazone's effectiveness and safety against a placebo in treating cALD. Men will randomly receive either the actual drug or an inactive substance to compare outcomes between the two groups.See study design
What are the potential side effects?
Potential side effects are not specified here but based on similar medications; they could include weight gain, fluid retention leading to swelling, heart issues, and possible liver changes. Side effects vary from person to person.
CALYX Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain scans show active lesions due to my condition.
Select...
I am not recommended or willing to undergo a stem cell transplant.
Select...
I am a man and 18 years old or older.
CALYX Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ interim analysis 1 (at 18 months of treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~interim analysis 1 (at 18 months of treatment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The primary endpoint will be the time to death or the subject becoming bedridden with a requirement for permanent ventilatory support, wichever comes earlier, in subjects treated with leriglitazone compared to placebo.
Secondary outcome measures
Change from Baseline in Loes Score
Change from Baseline in Loes Score.
CALYX Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: LeriglitazoneActive Control1 Intervention
Leriglitazone Treatment
Group II: PlaceboPlacebo Group1 Intervention
Placebo
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Who is running the clinical trial?
Minoryx Therapeutics, S.L.Lead Sponsor
4 Previous Clinical Trials
197 Total Patients Enrolled
3 Trials studying Adrenoleukodystrophy
158 Patients Enrolled for Adrenoleukodystrophy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a bone marrow transplant or gene therapy treatment.I have been diagnosed with diabetes.I do not have major disabilities, except possibly needing a wheelchair or having incontinence.Your Loes score is between 0.5 and 12 during the screening.I do not have significant memory or thinking problems that would stop me from participating in the study.My brain scans show active lesions due to my condition.I have taken honokiol, pioglitazone, or similar drugs in the last 3 months.I am not recommended or willing to undergo a stem cell transplant.I am a man and 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Leriglitazone
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare facilities are currently conducting this research trial?
"Currently, the trial is recruiting at seven sites across America. These include University of Florida Board in Florida City; Kennedy Krieger Institute in Baltimore; and Massachusetts General Hospital in Boston beside other 4 locations."
Answered by AI
Are there any hazardous risks associated with taking Leriglitazone?
"There is ample clinical data demonstrating leriglitazone's safety, thus it received a rating of 3."
Answered by AI
Are researchers at this time accruing participants for the trial?
"According to clinicaltrials.gov, this particular research initiative is no longer seeking participants having last been updated on April 5th 2023. Nonetheless, there are presently 15 other medical trials that remain open to enrollment."
Answered by AI
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