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Lorenzo's Oil in Asymptomatic X-linked Adrenoleukodystrophy
NCT00004418Phase 2
Key facts
- Status
- Terminated
- Start
- Apr 1998
- Primary completion
- Dec 2014
- Countries
- 1
- Sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger
- Modality
- Small Molecules
- Drugs
- Lorenzo's oil
- Conditions
- X-linked adrenoleukodystrophy (X-ALD)
01
Overview
Phase 2, open-label, single-arm trial of Lorenzo's oil in X-linked adrenoleukodystrophy (X-ALD), sponsored by Hugo W. Moser Research Institute at Kennedy Krieger. Primary endpoint: Change From Baseline in Very Long Chain Fatty Acids (VLCFA) Blood Levels at 10 years. Started Apr 1998; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Glyceryl trierucate/glyceryl trioleate
Lorenzo's Oil daily
03
Endpoints
Primary
Change From Baseline in Very Long Chain Fatty Acids (VLCFA) Blood Levels
Secondary
Number of Participants With T2 MRI Abnormality
Frequency and Severity of Neurological Disability
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