NCT05819866|Active Not RecruitingPhase 3FDA Drug
A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adult Male Subjects With Cerebral Adrenoleukodystrophy
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Sponsor study identifier
interventional
40
8 countries
11
Study Start
July 12, 2023
Actual (reported)Primary Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adults Male Subjects with Cerebral Adrenoleukodystrophy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 23, 2023
Actual (reported)April 19, 2023
Actual (reported)July 12, 2023
Actual (reported)May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
Interim analysis 1 (at 18 months of treatment)
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.
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.
Interim analysis 2 (at 27 months of treatment)
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.
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.
Final analysis (at 36 months of treatment)
Change from Baseline in Loes Score.
Interim analysis 1 (at 18 months of treatment)
Change from Baseline in Loes Score
Interim analysis 2 (at 27 months of treatment)
Change from Baseline in Loes Score
Final analysis (at 36 months of treatment)
Leriglitazone Treatment
Placebo
Leriglitazone at a strength of 15 mg/ml. Once-daily dosing at an initial volume of 10 ml
Placebo will match the study drug visually and by taste
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Stanford University Medical Center
Palo Alto, California, 94304-5978, United States
Kennedy Krieger Institute
Baltimore, Maryland, 21205, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Minnesota
Minneota, Minnesota, 55455, United States
Hospital Austral
Buenos Aires, Argentina
Federal University of Sao Paulo
São Paulo, Brazil
ICM La Pitie Salpetriere
Paris, 75013, France
First Submitted
March 23, 2023
First Posted
April 19, 2023
Study Start
July 12, 2023
Actual (reported)Primary Completion
May 2027
EstimatedRegistry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Klinik und Poliklinik für Neurologie-Leipzig
Leipzig, 04103, Germany
Sir Ganga Ram Hospital
New Delhi, 110060, India
Hospital 12 de Octubre
Madrid, 28041, Spain
National Hospital for Neurology and Neurosurgery
London, WC1N 3AX, United Kingdom
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 29, 2026
Record last verified: 2026-07
Study fields come from the primary record; confirmed relationships can use other sources. Selecting a record here changes its provenance and downloads, without replacing the displayed study fields.
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Source: ClinicalTrials.gov.
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