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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01165060 |
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Date of registration:
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13/07/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Bezafibrate on the Level of Very Long Chain Fatty Acids (VLCFA) in X-linked Adrenoleukodystrophy (X-ALD)
BEZA |
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Scientific title:
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Effect of Bezafibrate on Very Long Chain Fatty Acid Metabolism in Men With X-linked Adrenoleukodystrophy (X-ALD) |
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Date of first enrolment:
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July 2010 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01165060 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Bwee Tien Poll - The, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- an age of 18 years or older
- capable of giving informed consent and capable of visiting the hospital for follow-up
visits
- no contra-indications for the use of bezafibrate, e.g. kidney- and/or liver disease.
- confirmed X-ALD, AMN phenotype (confirmed by VLCFA analysis or analysis of the ABCD1
gene)
Exclusion Criteria:
- use of medication that lowers cholesterol and/or triglycerides (e.g. statins)
- liver disease or and increase in serum CK of more than 3 times the baseline level
- treatment with Lorenzo's oil in the 8 weeks preceding the trial
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Adrenomyeloneuropathy
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X-linked Adrenoleukodystrophy
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Intervention(s)
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Drug: Bezafibrate
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Primary Outcome(s)
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Very long chain fatty acids (VLCFA; C22:0, C24:0 and C26:0) in plasma, lymphocytes and erythrocytes.
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Cholesterol (total-, HDL, and LDL-cholesterol) in plasma.
[Time Frame: 24 weeks]
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Side effects
[Time Frame: At 4, 8, 12, 16, 20 and 24 weeks.]
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Secondary ID(s)
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MEC 09/278
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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