Randomized Study of Beta Interferon and Thalidomide in Patients With Adrenoleukodystrophy

NCT00004450 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-03-25

No results posted yet for this study

Summary

OBJECTIVES: I. Evaluate the efficacy of interferon beta and thalidomide in male patients with adrenoleukodystrophy who show evidence of brain inflammatory response and are receiving concurrent glyceryl trierucate and glyceryl trioleate (Lorenzo's oil).

II. Evaluate the progress of the disease and possible side effects of the medication in these patients.

Conditions

  • Adrenoleukodystrophy

Interventions

DRUG

glyceryl trierucate

DRUG

glyceryl trioleate

DRUG

interferon beta

DRUG

thalidomide

Sponsors & Collaborators

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

    collaborator OTHER
  • FDA Office of Orphan Products Development

    lead FED

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
4 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-08-31
Completion
2000-11-30

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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 NCT00004450 on ClinicalTrials.gov