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NCT05819866 · ClinicalTrials.gov registry record · Phase 3
A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adult Male Subjects With Cerebral Adrenoleukodystrophy
A Phase 3 study of Cerebral Adrenoleukodystrophy (CALD), sponsored by Minoryx Therapeutics, S.L..
- Recruiting
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
- 13
- Study locations
NCT05819866: Recruiting Phase 3 study of Cerebral Adrenoleukodystrophy (CALD), sponsored by Minoryx Therapeutics, S.L..
NCT05819866 is a Phase 3 study of Cerebral Adrenoleukodystrophy (CALD) that is actively recruiting participants, run by Minoryx Therapeutics, S.L.. The registered enrollment target is 40 participants, below the 72-participant average among 3 other Cerebral Adrenoleukodystrophy (CALD) trials with a reported enrollment target (44% lower). The trial reports 13 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05819866, a Phase 3 study of Cerebral Adrenoleukodystrophy (CALD), is actively recruiting participants, sponsored by Minoryx Therapeutics, S.L..
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
- 13
- Study locations
Study Summary
A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adults Male Subjects with Cerebral Adrenoleukodystrophy.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Leriglitazone
Study Locations (13)
Other
- Hospital Austral - Buenos Aires
- Federal University of Sao Paulo - São Paulo
- ICM La Pitie Salpetriere - Paris
- Klinik und Poliklinik für Neurologie-Leipzig - Leipzig
- Sir Ganga Ram Hospital - New Delhi
- Hospital 12 de Octubre - Madrid
- National Hospital for Neurology and Neurosurgery - London
California
- Stanford University Medical Center - Palo Alto
Florida
- Neuro Medicine Hospital / UF Health - Gainesville
Maryland
- Kennedy Krieger Institute - Baltimore
Massachusetts
- Massachusetts General Hospital - Boston
Minnesota
- University of Minnesota - Minneota
Utah
- Health University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-07-12 |
| Est. Completion | 2027-05 |
| Phase | Phase 3 |
What NCT05819866 shows while recruiting
NCT05819866 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 72-participant average among 3 other Cerebral Adrenoleukodystrophy (CALD) trials with a reported enrollment target (44% lower).
The record links to 1 condition, with Cerebral Adrenoleukodystrophy (CALD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05819866 lists 13 locations in 7 states (Other, California, Florida).
Frequently Asked Questions
What is clinical trial NCT05819866 about?
NCT05819866 is a clinical study titled "A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adult Male Subjects With Cerebral Adrenoleukodystrophy". A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adults Male Subjects with Cerebral Adrenoleukodystrophy.
What is the current status of trial NCT05819866?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2023-07-12. Estimated completion is 2027-05.
What conditions does trial NCT05819866 study?
This clinical trial studies the following conditions: Cerebral Adrenoleukodystrophy (CALD).
What interventions are being tested in trial NCT05819866?
The interventions under investigation include: Placebo (DRUG), Leriglitazone (DRUG).
Who is sponsoring clinical trial NCT05819866?
This trial is sponsored by Minoryx Therapeutics, S.L., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05819866 being conducted?
This trial has 13 study locations across California, Florida, Maryland, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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