Randomized Study of Beta Interferon and Thalidomide in Patients With Adrenoleukodystrophy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004450|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
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.
|Condition or disease||Intervention/treatment|
|Adrenoleukodystrophy||Drug: glyceryl trierucate Drug: glyceryl trioleate Drug: interferon beta Drug: thalidomide|
PROTOCOL OUTLINE: This is randomized, double blind, placebo controlled study. Patients are randomized to receive beta interferon and thalidomide placebo (arm I), thalidomide and beta interferon placebo (arm II), or placebo for both beta interferon and thalidomide (arm III). Patients receive interferon beta by subcutaneous injection and thalidomide orally. All patients are maintained on glyceryl trierucate and glyceryl trioleate (Lorenzo's oil) therapy.
Patients are followed at 3, 6, and 12 months and then may be followed every 6 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Study Start Date :||August 1998|
|Estimated Study Completion Date :||November 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004450
|Study Chair:||Hugo Wolfgang Moser||Hugo W. Moser Research Institute at Kennedy Krieger, Inc.|