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
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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