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Effect of Glycerol Trierucate on Clinical Course of Adrenoleukodystrophy

NCT00004418 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2020-10-23

Study results available
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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.

Conditions

  • Adrenoleukodystrophy

Interventions

DRUG

glyceryl trierucate/glyceryl trioleate

Administration of glyceryl trierucate/glyceryl trioleate

Sponsors & Collaborators

  • Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    lead OTHER

Principal Investigators

  • Gerald V Raymond, M.D. · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Months
Max Age
8 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-04-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004418 on ClinicalTrials.gov