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A Phase III Trial of Lorenzo's Oil in Adrenomyeloneuropathy

NCT00545597 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2012-03-02

No results posted yet for this study

Summary

Study of the use of Lorenzo's oil in adults with adrenomyeloneuropathy, the adult form of Lorenzo's oil.

Conditions

  • Adrenomyeloneuropathy
  • Adrenoleukodystrophy

Interventions

DRUG

Lorenzo's oil

4:1 glyceryl trioleate-glyceryl trierucate (Lorenzo's oil)given orally, daily as approximately 10% of nutritional calories with supplementation.

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2007-10-31
Completion
2007-10-31

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 NCT00545597 on ClinicalTrials.gov