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NCT00004418 · ClinicalTrials.gov registry record · Phase 2

Effect of Glycerol Trierucate on Clinical Course of Adrenoleukodystrophy

A Phase 2 study, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.

Terminated
Registry status
Phase 2
Development phase
126
Enrollment target

NCT00004418: Clinical Trial Phase 2 study, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.

NCT00004418 is a Phase 2 study that was terminated before completion, run by Hugo W. Moser Research Institute at Kennedy Krieger. The registered enrollment target is 126 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00004418, a Phase 2 study, was terminated before completion, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.

TERMINATED
Registry status
Phase 2
Development phase
126 participants
Enrollment target

Study Summary

OBJECTIVES: I. Evaluate the clinical efficacy of combination glyceryl trierucate and glyceryl trioleate (Lorenzo's Oil) therapy in boys with X-linked adrenoleukodystrophy. II. Compare the frequency and severity of neurological disability of study patients with untreated historical controls.

Primary Outcome

we will assess the change in very long-chain fatty acids as determined by reduction of blood level baseline C26:0 level.

Interventions

  • DRUG glyceryl trierucate/glyceryl trioleate

Trial Details

FieldValue
Enrollment Target 126 participants
Start Date 1998-04
Est. Completion 2014-12
Phase Phase 2

Why NCT00004418 stopped before completion

NCT00004418 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which glyceryl trierucate/glyceryl trioleate is the first listed.

NCT00004418 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00004418 about?

NCT00004418 is a clinical study titled "Effect of Glycerol Trierucate on Clinical Course of Adrenoleukodystrophy". OBJECTIVES: I. Evaluate the clinical efficacy of combination glyceryl trierucate and glyceryl trioleate (Lorenzo's Oil) therapy in boys with X-linked adrenoleukodystrophy. II. Compare the frequency and severity of neurological disability of study patients with untreated historical controls.

What is the current status of trial NCT00004418?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 1998-04. Estimated completion is 2014-12.

What interventions are being tested in trial NCT00004418?

The interventions under investigation include: glyceryl trierucate/glyceryl trioleate (DRUG).

Who is sponsoring clinical trial NCT00004418?

This trial is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00004418's enrollment target sits among peer trials

126 556th of 2000 higher than 1,443 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00004418, the US trial registry maintained by the National Library of Medicine. NCT00004418 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.