drugset / Trial / NCT00004450
Randomized Study of Beta Interferon and Thalidomide in Patients With Adrenoleukodystrophy
Completed
60 enrolled
FDA Office of Orphan Products Development
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · collab
RandomizedDouble-blindTreatment
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.
Timeline
- Start
- 1998-08
- Primary completion
- —
- Completion
- 2000-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Interferon-beta | Protein / enzyme biologic | — | Subcutaneous |
| Subject | Thalidomide | Other / unclassified | — | Oral |
| Background | glyceryl trierucate | Small molecule | — | — |
| Background | glyceryl trioleate | Small molecule | — | — |